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Description | |
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1
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Artificial Intelligence (AI) Life Sciences, USFDA, INFORMED, Pre-Cert 1.0 | This article talks about Artificial Intelligence (AI) as a next big step for life science innovation, and the initiation of pilot version of a Pre-certification program and taken up INFORMED to broaden the spectrum of applications of AI. |
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2
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Brexit, eSubmission Portal, MHRA, UK, Europe, electronic Submissions, CESP | This article talks about proposed eSubmission Portal, the new system to be taken place as a result of Brexit for regulatory submissions of EU medicines, medical devices to MHRA, Its registration and submission process. |
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3
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Health canada's action plan on medical devices, Canada | Health canada's action plan on medical devices, Canada |
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4
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Halal cosmetic products, cosmetics, halal products, BPJPH, FHCB, HCBs | This article talks about the growing demand for halal cosmetics & personal care products, as Halal products have enough opportunities in the market the countries like Malaysia, Indonesia & India are contributing the most towards it. |
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5
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Brexit, Artwork challenges, Pharmaceuticals, EMA, MHRA, MAHs, Europe | https://www.freyrsolutions.com/blog/brexit-artwork-challenges-for-pharma-industry |
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6
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Medical Device 510 k, 510 k Clearance, FDA, CDRH, Medical devices | This article talks about the modernization of 510(k) clearance pathway proposed by FDA and CDRH on pre-market approval of novel devices to ensure the safety and performance of the devices. |
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7
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Medical device reclassification, TGA, Australia, EU MDR, Class III | This article talks about the newly proposed rule by Australia’s TGA regarding reclassification of spinal implantable device from Class IIb to Class III to align with EU MDR. |
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8
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8 new medical device additions, CDSCO, regulation, MHHFW, India | This article talks about the addition of eight new devices to CDSCO’s list of regulated medical devices in India. These devices are required to be registered with the local health authority before 1st January 2020. |
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9
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Cosmetic Compliance, Emerging Technologies, IQPC, 2019 | This article talks about the importance of cosmetic compliance and adopting new technology trends by cosmetic companies, which can help them streamline and complement their Regulatory efforts. |
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10
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Cosmetic Compliance, Emerging Technologies, IQPC, 2019 | Cosmetic Compliance, new technologies, Regulatory Trends, cosmetic companies, IQPC cosmetic compliance spring 2019, Good Manufacturing Practices (GMPs) |
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11
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Cosmetic Compliance, Emerging Technologies, IQPC, 2019 | This article talks about the importance of cosmetic compliance and adopting new technology trends by cosmetic companies, which can help them streamline and complement their Regulatory efforts. |
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12
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South Korea Cosmetics market, MFDS, South Korea, business opportunities | https://www.freyrsolutions.com/blog/south-korea-cosmetics-market-preliminary-report |
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13
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South Korea Cosmetics market, MFDS, South Korea, business opportunities | This article talks about the steady increase of cosmetics market in South Korea, business opportunities, Cosmetics categorization, regulations and labeling requirements to comply with MFDS. |
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14
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Type III DMF submissions, ectd format, FDA deadline | This article talks about the FDA update on extending deadline for Type III DMF submissions in eCTD format, to May 5, 2020 and its requirements & guidance. |
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15
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South Korea Cosmetics market, MFDS, South Korea, business opportunities | This article talks about the steady increase of cosmetics market in South Korea, business opportunities, Cosmetics categorization, regulations and labeling requirements to comply with MFDS. |
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16
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FDA finalized seven major rules, FSMA, food products | This article talks about FDA finalized seven major rules to implement Food Safety Modernization Act (FSMA) in order to supply safety food products and avoid contamination. |
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17
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Manufacturing site change supplement guidance from FDA, PMA, Medical devices | This article talks about FDA’s final guidance on manufacturing site change supplement for the medical device manufacturers to be compliant with the regulations during the submission of a premarket approval application (PMA) supplement. |
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18
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EU Cosmetic Claims, Annex III - Free From, Annex IV - Hypoallergenic, cosmetic products | This article talks about the EU cosmetic update on mandating Annex III - free from claims and introducing Annex IV - hypoallergenic claim from July 1, 2019. |
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19
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Cosmetics labeling requirements, US, Europe, China, Australia, India, Korea | This article talks about the Cosmetic label element requirements in various regions, so that manufacturers will be compliant with the respective Health Authority regulations and market the products. |
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20
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Effective IND Application Submission Process and Components Involved | This article talks about the Effective IND submission process and a list of components provided by the drug manufacturers that make a flawless IND submissions. |
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21
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Jordan's JFDA accepts Submissions in JO eCTD format | This article talks about Jordan Food and Drug Administration (JFDA) started accepting marketing authorization submissions in eCTD format from March 1, 2019 and has recently released a guidance document for applicants giving the detailed instructions on submission. |
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22
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FSSAI proposed a draft regulation on infant nutrition in India | This article talks about FSSAI proposed a draft regulation on infant food in India, an updated version to the existing regulations released in 2011 for infant food nutrition to ensure safety of infant nutrition. |
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23
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Mutual Recognition Agreement on GMP inspections between EU & US | This article talks about EU and USA Mutual Recognition Agreement (MRA) on Good Manufacturing Practice (GMP) inspections for human medicines. |
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24
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EDQM mandates CEP Application submissions in eCTD format | This article talks about the EDQM revised roadmap on mandatory eCTD format for all Certificate of Suitability (CEP) application submissions, will be effective from January 1, 2020. |
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25
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New Cosmetics Regulations in UK post Brexit | This article talks about the new cosmetics regulations proposed by CTPA in UK in the light of Brexit. |
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26
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US calls for delay in implementation of EU’s MDR & IVDR for three more years | This article talks about EU’s MDR and IVDR implementation and the request received from US for a delay for three years based on some reasons. |
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27
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FDA's ANDA stage wise submission criteria to avoid Refuse to Receive, RTR | This article talks about the ANDA stage wise submission criteria for applicants in order to avoid Refuse to Receive (RTRs) from FDA during generic drug approval process. |
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28
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FDA Final Guidance on Child-Resistant Packaging(CRP) statements in drug labels | This article talks about FDA’s final guidance on Child-Resistant Packaging (CRP) statement in drug labels as per Consumer Product Safety Commission (CPSC) regulations. |
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29
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Regulatory Labeling Management Software - Freyr Label 360 | Freyr label 360 is an end-to-end labeling software that supports pharma, biotech, medical devices and consumer care companies in global product label management. |
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30
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Core Label management software, Label Tracking | Freyr LABEL 360 | Freyr label 360 is a core label management software that helps life sciences companies in managing product labeling right from creation, development, authoring, tracking and reporting. |
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31
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Health Canada’s Mandate on DMF Submissions in eCTD format | This article talks about Health Canada’s (HC) mandate on Type I, II, III, IV Drug Master File (DMF) Submissions in eCTD format and is effective from January 1, 2020. |
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32
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France ARPP's New Labeling rules on Cosmetic Products | This article talks about the French professional advertising Regulatory authority (ARPP) published new recommendations on usage of cosmetic products that are effective from July 1, 2019. |
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33
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Compliance labeling and it's challenges | This article talks about the labeling compliance and the challenges involved in label management. |
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34
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Compliance labeling and it's challenges | This article talks about the labeling compliance and the challenges involved in label management. |
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35
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Taiwan FDA’s new Regulations on safety of Cosmetic products | This article talks about the Taiwan FDA’s new cosmetics regulations on safety of beauty products effective from July 1, 2019. |
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36
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TGA Assessed Claim - Usage on Medicine Labels | This article talks about the TGA announced guidelines for using “TGA assessed claim”, symbol and/or statement on medicine labels by sponsors of assessed listed medicines and registered complementary medicines. |
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37
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eCTD submissions for better Health Authority Compliance | This article talks about the importance of regulatory Submissions in eCTD format, as many of the health authorities have made eCTD format mandatory for master file submissions. |
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38
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Malaysia Cosmetic Notification procedure for Market Entry | This article talks about the Malaysia Cosmetic Notification Procedure for product registration to meet NPRA regulations for successful market entry. |
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39
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MFDS South Korea to align with EU Regulations for Cosmetic safety standards | This article talks about the MFDS South Korea to align with EU regulations to increase the safety of cosmetic products. |
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40
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MoHAP Launches National Nutrition Guidelines for food Safety | This article talks about MoHAP’s launch of National Nutrition Guidelines in collaboration with the UAE’s Food Security Office to enhance the safety of food products. |
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41
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FDA Finalized List of Class II Medical Device Types from 510(k) exemption | This article talks about the FDA’s announcement on the proposed final list of Class II medical device types that will be exempted from 510(k) premarket notification requirements. |
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42
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Regulatory Updates in 2019 on Pharma, Medical Devices, Cosmetics and Food Supplements | This article talks about the Regulatory Changes made by Health authorities (FDA, TGA, CDSCO, HC, NMPA, EMA) on Pharmaceuticals, Medical Devices, Cosmetics and Food Supplements in 2019. |
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43
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EU MDR new Corrigendum for Class I Medical Devices | This article talks about the EU’s new corrigendum on Class I reusable medical devices are expected to get an additional four years, i.e. until May 26, 2024, to comply with the MDR. |
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44
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South Korea MFDS reduces some STED file Submissions for Class IV Medical Devices | This article talks about the South Korea’s MFDS announced that the agency no longer require the submission of full summary technical documentation (STED) files for class IV medical devices. |
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45
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South Korea MFDS reduces some STED file Submissions for Class IV Medical Devices | This article talks about the South Korea’s MFDS announced that the agency no longer require the submission of full summary technical documentation (STED) files for class IV medical devices. |
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46
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FDA implemented FSMA regulations for food safety tracking | This article talks about the update from FDA that prioritizes the food safety tracking by successful implementation of FSMA regulations to avoid deaths caused by preventable contamination. |
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47
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Regulatory updates in 2020, pharma, medical devices, cosmetics, supplements | This article talks about the regulatory updates shared by health authorities(Health Canada, EDQM, EMA, TGA, FDA, CDSCO) in 2020 and further on lifesciences segments like pharma, medical devices, food supplements and cosmetics. |
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48
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FDA finalizes electronic submission rule for medical devices | This article talks about the FDA’s final rule on medical devices to submit premarket notification/submissions in electronic format that will be effective from January 15, 2020. |
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49
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eCTD publishing Software, eCTD format, eCTD validator | Freyr SUBMIT Pro is an prominent eCTD publishing Software with various features like Inbuilt eCTD validator and viewer, submission tracking, HA query management, rDMS intergation and many more. |
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50
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Multi-parameter patient monitor Registration/Notification in India, CDSCO, Covid-19 | Freyr’s regulatory services in India for Multi-parameter patient monitor span across registration, notification and classification as per CDSCO regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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51
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Neonatal Resuscitation Table Registration/Notification in USA, US FDA, Covid-19 | Freyr’s regulatory services in USA for Neonatal Resuscitation Table span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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52
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Neonatal Resuscitation Table Registration/Notification in India, CDSCO, Covid-19 | Freyr’s regulatory services in India for Neonatal Resuscitation Table span across registration, notification and classification as per CDSCO regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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53
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Nasal Spray/Drops Registration/Notification in USA, US FDA, Covid-19 | Freyr’s regulatory services in USA for Nasal Spray/Drops span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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54
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Nasal Spray/Drops Registration/Notification in India, CDSCO, Covid-19 | Freyr’s regulatory services in India for Nasal Spray/Drops span across registration, notification and classification as per CDSCO regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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55
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Liquid soap Registration/Notification in USA, US FDA, Covid-19 | Freyr’s regulatory services in USA for Liquid soap span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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56
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Liquid soap Registration/Notification in India, CDSCO, Covid-19 | Freyr’s regulatory services in India for Liquid soap span across registration, notification and classification as per CDSCO regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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57
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Infusion pump Registration/Notification in USA, US FDA, Covid-19 | Freyr’s regulatory services in USA for Infusion pump span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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58
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Infusion pump Registration/Notification in USA, US FDA, Covid-19 | Freyr’s regulatory services in USA for Infusion pump span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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59
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Infusion pump Registration/Notification in India, CDSCO, Covid-19 | Freyr’s regulatory services in India for Infusion pump span across registration, notification and classification as per CDSCO regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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60
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Protective Gown Registration/Notification in USA, US FDA, Covid-19 | Freyr’s regulatory services in USA for Protective Gown span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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61
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Diagnostic Kits (Rapid Testing) Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for Diagnostic Kits (Rapid Testing) span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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62
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Diagnostic Kits Registration/Notification in the USA, US FDA, Covid-19 | Freyr provides regulatory services in USA for Diagnostic Kits span across registration and notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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63
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Diagnostic Kits Registration/Notification in the USA, US FDA, Covid-19 | Freyr provides regulatory services in USA for Diagnostic Kits span across registration and notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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64
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Diagnostic Kits Registration/Notification in India, CDSCO, Covid-19 | Freyr supports regulatory services in India for Diagnostic Kits span across registration and notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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65
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Defibrillator Registration/Notification in USA, US FDA, Covid-19 | Freyr supports regulatory services in USA for Defibrillator span across registration and notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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66
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Defibrillator Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for Defibrillator span across registration and notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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67
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Chlorine HTH 70 Registration/Notification in USA, US FDA, Covid-19 | Freyr provides regulatory services in USA for Chlorine (HTH 70%) span across registration, notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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68
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Chlorine HTH 70 Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for Chlorine (HTH 70%) span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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69
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Autoclave Registration/Notification in USA, US FDA, Covid-19 | Freyr provides regulatory services in USA for Autoclave span across registration and notification and classification as per US FDA Health Authority regulations to the meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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70
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Autoclave Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for Autoclave span across registration and notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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71
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Apron registration/Notification in USA, USFDA, Covid-19 | Freyr’s regulatory services in USA for Apron (disposable, heavy duty or reusable) span across registration, notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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72
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Apron registration/Notification in India, CDSCO, Covid-19 | Freyr’s regulatory services in India for Apron (disposable, heavy duty or reusable) span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in pandemic emergency situation for early market access. |
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73
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Thermometer Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for Thermometer span across registration and notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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74
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Thermometer Registration/Notification in USA, US FDA, Covid-19 | Freyr provides regulatory services in USA for Thermometer span across registration and notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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75
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Suction Bulb Registration/Notification in USA, US FDA, Covid-19 | Freyr provides regulatory services in USA for Suction Bulb span across registration and notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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76
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Suction Bulb Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for Suction Bulb span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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77
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Suction pump Registration/Notification in USA, US FDA, Covid-19 | Freyr provides regulatory services in USA for suction pump span across registration and notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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78
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Suction pump Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for suction pump span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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79
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Self-inflating Bag Registration/Notification in USA, US FDA, Covid-19 | Freyr provides regulatory services in USA for Self-inflating Bag span across registration, notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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80
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Self-inflating Bag Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for Self-inflating Bag span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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81
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Laryngoscope Registration/Notification in India, CDSCO, Covid-19 | Freyr provides regulatory services in India for Laryngoscope span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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82
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Cricothyrotomy kit Registration/Notification in USA, US FDA, Covid-19 | Freyr supports regulatory services in USA for Cricothyrotomy kit span across registration, notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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83
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Cricothyrotomy kit Registration/Notification in India, CDSCO, Covid-19 | Freyr supports regulatory services in India for Cricothyrotomy kit span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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84
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Continuous Positive Airway Pressure (CPAP) Registration/Notification in USA, US FDA, Covid-19 | Freyr’s regulatory services in USA for Continuous Positive Airway Pressure (CPAP) span across registration, notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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85
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Continuous Positive Airway Pressure (CPAP) Registration/Notification in India, CDSCO, Covid-19 | Freyr’s regulatory services in India for Continuous Positive Airway Pressure(CPAP) span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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86
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Hand sanitizer Registration/Notification in USA, US FDA, Covid-19 | Freyr supports regulatory services in USA for Hand sanitizer span across registration, notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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87
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Hand sanitizer Registration/Notification in India, CDSCO, Covid-19 | Freyr supports regulatory services in India for Hand sanitizer span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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88
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Surgical Masks and N95 Respirators registration/Notification in India, CDSCO, Covid-19 | Freyr’s regulatory services in India for Surgical/Face Masks and N95 Respirators span across registration, notification and classification as per CDSCO Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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89
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Surgical Masks and N95 Respirators registration/Notification in USA, US FDA, Covid-19 | Freyr’s regulatory services in USA for Surgical/Face Masks and N95 Respirators span across registration, notification and classification as per US FDA Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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90
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Surgical Masks and N95 Respirators registration/Notification in Mexico, COFEPRIS, Covid-19 | Freyr’s regulatory services in Mexico for Surgical/Face Masks and N95 Respirators span across registration, notification and classification as per COFEPRIS Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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91
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Hand Sanitizer Registration/Notification in Canada, Health Canada, Covid-19 | Freyr’s regulatory services in Canada for Hand Sanitizer span across registration, notification and classification as per Health Canada Health Authority regulations to meet market entry requirements and fast track approval process for Covid-19 in the pandemic emergency situation for early market access. |
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92
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Best Quality Airmask for sale in USA, ECO Airmasks | Taevas Life Sciences Inc, a Princeton, New Jersey based commercial and regulatory service provider of speciality medical devices, niche pharmaceuticals and consumer healthcare products - is pleaded to launch ECO Airmasks are reusable, washable & eco-friendly masks available online across USA at affordable prices. |
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93
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Multi-vitamin Supplement Registration/Notification in Canada, Health Canada, Covid-19 | Freyr provide regulatory services in Canada for Immune boosting Multi-vitamin supplements in registration, notification, classification, label and formulation review as per Health Canada regulations to meet market entry requirements and fast track approvals for Covid-19 in the pandemic emergency situation for early market access. |
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94
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Immunity Food Products Registration and Notification in the Netherlands | Freyr provide regulatory services in Netherlands for Immune boosting Turmeric (Curcumin), Moringa, Elderberry supplement product in registration, notification, classification, label and formulation review as per local HA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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95
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Immunity Food Products Registration and Notification in Hungary | Freyr provide regulatory services in Hungary for Immune boosting Turmeric (Curcumin), Moringa, Elderberry supplement product in registration, notification, classification, label and formulation review as per OGYÉI regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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96
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Immunity Food Products Registration/Notification in Germany | Freyr provide regulatory services in Germany for Immune boosting Turmeric (Curcumin), Moringa, Elderberry supplement product in registration, notification, classification, label and formulation review as per BfR regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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97
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Immunity Food Products Registration and Notification in Singapore | Freyr provide regulatory services in Singapore for Immune boosting Turmeric (Curcumin), Moringa, Elderberry supplement product in registration, notification, classification, label and formulation review as per HSA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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98
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Immunity Food Products Registration and Notification in Vietnam | Freyr provide regulatory services in Vietnam for Immune boosting Turmeric (Curcumin), Moringa, Elderberry supplement product in registration, notification, classification, label and formulation review as per MoH/MARD/MOIT regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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99
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Immunity Food Products Registration/Notification in Philippines | Freyr provide regulatory services in Philippines for Immune boosting Turmeric (Curcumin), Moringa, Elderberry supplement product in registration, notification, classification, label and formulation review as per Philippines FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergenc |
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100
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Probiotics/Prebiotics Registration and Notification India | Freyr’s regulatory services in India for Probiotics span across registration, notification and classification as per FSSAI regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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101
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Health Canada guidance on anonymization and redaction of clinical data | With an aim to make anonymized clinical information in drug submissions and medical devices applications publicly accessible, Health Canada released a guidance document named as Health Canada's Public Release of Clinical Information (PRCI). Adhering to Canada’s Privacy Act, this document on clinical information enables independent re-analyses of data, completion of Health Canada’s Regulatory review process, fosters new research queries and aids the healthcare professionals, public, industries and other stakeholders to better understand the clinical aspects and make appropriate decisions about health. |
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102
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Freyr launched web platforms for Cosmetics, Food Supplements and Chemical business services | As we look at these challenging times for manufacturers across the life sciences industry, of course, not in terms of manufacturing products, but to market them across the globe compliantly, we understand there is a dire need for effective Regulatory solutions and services to ensure products compliant market entry. As always, we believe that they need a dedicated approach and a clear-cut service line. Therefore, to help manufacturers comprehend Freyr’s capabilities more clearly, Freyr has come up with exclusive web platforms for the Beauty, Wellness and Health (BWH) business lines – Cosmetics, Food and Food Supplements, Chemicals & Biocides. |
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103
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Health Canada regulations on Hand Sanitizers ingredient usage | This article talks about the Health Canada's update on regulatory requirements on ingredients used in Hand sanitizers to ensure the safety and effectiveness of the product. |
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104
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US FDA Relaxes Regulatory Requirements for Surgical Gowns and Gloves during Covid-19 pandemic | This article talks about the US FDA's guidance document on relaxation of regulatory requirements for surgical gowns and surgical gloves during Covid-19 pandemic. |
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105
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Autoclave Registration/Notification in Belgium, FAMHP, Covid-19 | Freyr provides regulatory services in Belgium for Autoclave span across product registration, notification and classification as per FAMHP health authority regulations to meet market entry requirements and fast track approvals during Covid-19 in the pandemic emergency situation for early market access. |
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106
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Autoclave Registration/Notification in Germany, BfArM, Covid-19 | Freyr provides regulatory services in Germany for Autoclave span across product registration, notification and classification as per BfArM health authority regulations to meet market entry requirements and fast track approvals during Covid-19 in the pandemic emergency situation for early market access. |
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107
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Autoclave Registration/Notification in Croatia, HALMED, Covid-19 | Freyr provides regulatory services in Croatia for Autoclave span across product registration, notification and classification as per HALMED health authority regulations to meet market entry requirements and fast track approvals during Covid-19 in the pandemic emergency situation for early market access. |
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Autoclave Registration/Notification in Bulgaria, BDA, Covid-19 | Freyr’s regulatory services in Bulgaria for Autoclave span across registration, notification and classification as per BDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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Autoclave Registration/Notification in Sweden, MPA, Covid-19 | Freyr provides regulatory services in Sweden for Autoclave span across product registration, notification and classification as per MPA health authority regulations to meet market entry requirements and fast track approvals during Covid-19 in the pandemic emergency situation for early market access. |
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Autoclave Registration/Notification in Spain, AEMPS, Covid-19 | Freyr’s regulatory services in Spain for Autoclave span across registration, notification and classification as per AEMPS regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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Autoclave Registration/Notification in Slovenia, JAZMP Covid-19 | Freyr provides regulatory services in Slovenia for Autoclave span across product registration, notification and classification as per JAZMP health authority regulations to meet market entry requirements and fast track approvals during Covid-19 in the pandemic emergency situation for early market access. |
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Autoclave Registration/Notification in Slovakia, SUKL, Covid-19 | Freyr’s regulatory services in Slovakia for Autoclave span across registration, notification and classification as per SUKL regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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Autoclave Registration/Notification in Romania, ANMDMR, Covid-19 | Freyr’s regulatory services in Romania for Autoclave span across registration, notification and classification as per ANMDMR regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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Autoclave Registration/Notification in Portugal, INFARMED, Covid-19 | Freyr’s regulatory services in Portugal for Autoclave span across registration, notification and classification as per INFARMED regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies. |
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EU released notice for sponsors to ensure Post-Brexit Compliance with Clinical Trial Rules | This article talks about the EU released notice for sponsors to ensure Post-Brexit compliance with Clinical trials rules before the transition period that is going to expires on December 31, 2020. |
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USFDA New Guidance on eSubmission formats for medical devices | This article talks about the USFDA guidance on medical device eSubmission formats for 510k premarket notification, De Novo submission and premarket application submissions for medical device registration. |
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Probiotics/Prebiotics Registration and Notification Canada | Probiotics are live microorganisms which when administered in adequate amount can confer health benefits on the host. Probiotics promote a healthy balance of gut bacteria and have been linked to a wide range of health benefits. Another category of food additive which is beneficial to the human body is – Prebiotics. These are non-digestible ingredients which help in boosting the immune system of human body. Both prebiotics and probiotics help in boosting the immune system of human body and inhibit the growth of harmful gut bacteria, while promoting the production of natural antibodies in the body. In the current scenario of COVID-19, Probiotics/Prebiotics are considered critical to boost the immunity. But with the decline in the global supply chains of Probiotics/Prebiotics, meeting the demand right on time would be challenging. |
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Probiotics/Prebiotics Registration and Notification Mexico | Probiotics are live microorganisms which when administered in adequate amount can confer health benefits on the host. Probiotics promote a healthy balance of gut bacteria and have been linked to a wide range of health benefits. Another category of food additive which is beneficial to the human body is – Prebiotics. These are non-digestible ingredients which help in boosting the immune system of human body. Both prebiotics and probiotics help in boosting the immune system of human body and inhibit the growth of harmful gut bacteria, while promoting the production of natural antibodies in the body. In the current scenario of COVID-19, probiotics/prebiotics are considered critical to boost the immunity. But with the decline in the global supply chains of probiotics/prebiotics, meeting the demand right on time would be challenging. |
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Probiotics/Prebiotics Registration and Notification in Australia and New Zealand | Probiotics are live microorganisms which when administered in adequate amount can confer health benefits on the host. Probiotics promote a healthy balance of gut bacteria and have been linked to a wide range of health benefits. Another category of food additive which is beneficial to the human body is – Prebiotics. These are non-digestible ingredients which help in boosting the immune system of human body. Both prebiotics and probiotics help in boosting the immune system of human body and inhibit the growth of harmful gut bacteria, while promoting the production of natural antibodies in the body. In the current scenario of COVID-19, Probiotics/Prebiotics are considered critical to boost the immunity. But with the decline in the global supply chains of Probiotics/Prebiotics, meeting the demand right on time would be challenging. |
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Probiotics/Prebiotics Registration and Notification in Australia and New Zealand | Probiotics are live microorganisms which when administered in adequate amount can confer health benefits on the host. Probiotics promote a healthy balance of gut bacteria and have been linked to a wide range of health benefits. Another category of food additive which is beneficial to the human body is – Prebiotics. These are non-digestible ingredients which help in boosting the immune system of human body. Both prebiotics and probiotics help in boosting the immune system of human body and inhibit the growth of harmful gut bacteria, while promoting the production of natural antibodies in the body. In the current scenario of COVID-19, Probiotics/Prebiotics are considered critical to boost the immunity. But with the decline in the global supply chains of Probiotics/Prebiotics, meeting the demand right on time would be challenging. |
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Autoclave Registration/Notification in Estonia | In the current scenario of COVID-19, Autoclave is considered as few of the critical products for immediate supply. But with the decline in the global supply chains of autoclave, meeting the demand right on time would be challenging. To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent autoclave manufacturer, you might be willing to market your product across the globe or to be specific in Estonia. But do you know how autoclave machine is classified in Estonia? How the State Agency of Medicines (SAM) and the health board regulates autoclave |
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Autoclave Registration/Notification in Finland | In the current scenario of COVID-19, Autoclave is considered as few of the critical products for immediate supply. But with the decline in the global supply chains of autoclave, meeting the demand right on time would be challenging. To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent autoclave manufacturer, you might be willing to market your product across the globe or to be specific in Finland. But do you know how autoclave machine is classified in Finland? How the Finnish Medicines Agency (FIMEA) regulates autoclave. |
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Autoclave Registration/Notification in France | In the current scenario of COVID-19, Autoclave is considered as few of the critical products for immediate supply. But with the decline in the global supply chains of autoclave, meeting the demand right on time would be challenging. To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent autoclave manufacturer, you might be willing to market your product across the globe or to be specific in France. But do you know how autoclave machine is classified in France? How the National Agency for the Safety of Medicines and Health Products (ANSM) regulates autoclave. |
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Suction Bulb Registration/Notification in Austria | In the current scenario of COVID-19, suction bulb is considered as one of the critical products for immediate supply. But with the decline in the global supply chains of suction bulb, meeting the demand right on time would be challenging. To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent suction bulb manufacturer, you might be willing to market your product across the globe or to be specific in Austria. But do you know how suction bulb is classified in Austria? How the AGES/MEA, Austrian Medicines and Medical Devices Agency regulates baby suction bulbs. |
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Suction Bulb Registration/Notification in Malta | In the current scenario of COVID-19, suction bulb is considered as one of the critical products for immediate supply. But with the decline in the global supply chains of suction bulb, meeting the demand right on time would be challenging. To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent suction bulb manufacturer, you might be willing to market your product across the globe or to be specific in Malta. But do you know how suction bulb is classified in Malta? How the Malta Medicines Authority (MMA) and the Malta Competition and Consumer Affairs Authority (MCCAA) regulates baby suction bulbs. |
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FDA Proposes Integrating Master File Component to NDI Notification | This article talks about the USFDA proposal on integrating master file component in NDI(New Dietary Ingredient) notification and implementation of NDI-MFs(Master Files) to streamline the notification process and reduce the paperwork by Agencies and Dietary supplements Manufacturers for compliance. |
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TGA Establishes AICIS Replacing the NICNAS | This article talks about the Australia’s TGA introduced new regulation on transition from NICNAS (National Industrial Chemicals Notification and Assessment Scheme) to AICIS (Australian Industrial Chemicals Introduction Scheme) which is effective from July 1, 2020, stay up to date and stay compliant. |
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ECHA released latest report on alternatives to animal testing | This article talks about the European Chemical Agency (ECHA) released latest report on alternatives to animal testing. |
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EU MDR Compliance of Medical Devices – Exclusive Webinar | This Webinar is all about the EU MDR regulations and requirements for medical devices manufacturers to understand & comply with new regulations which will come into effect from May 26, 2021, join us for the webinar on October 7, 2020, 10:00 AM EST/EDT | 3:00 PM BST | 7:30 PM IST. |
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Impact of Brexit on the Pharmaceutical Companies | This article talks about the impact of Brexit on pharmaceutical law and recommended actions for pharma companies to be prepared for any of the Brexit outcomes. |
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Classification of Non-Notified medical devices and In-Vitro Diagnostics in India | This article talks about the CDSCO’s released notices regarding the classification of the Non-Notified medical devices and In-Vitro Diagnostics devices in India. |
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Ireland's HPRA update on extended implementation time for labels and leaflets | This article talks about the Ireland’s HPRA published temporarily extended implementation time for labeling or packaging leaflets updates to ensure the availability of medicines in Ireland during Covid-19 pandemic. |
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FDA's final guidance on Biological Evaluation of Medical Devices | This article talks about the FDA’s final guidance on Biological Evaluation of Medical Devices to guide device manufacturers on usage of ISO standard 10993-1. |
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China's NMPA published final version of CSAR effective from Jan 1, 2021 | This article talks about the China’s NMPA published final version of Cosmetic Supervision and Administration Regulation (CSAR) for safety and efficacy of cosmetics products, which is effective from January 1, 2021. |
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Australia introduced a ban on the usage of animal test data for cosmetics | This article talks about Australia’s new update on implementing a ban on the usage of animal test data for cosmetics and it is effective from July 1,2020. |
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EMA’s revised guidelines on the quality of water for pharmaceutical use | The article talks about the EMA published a revised guidelines on the quality of water used for pharmaceuticals, which will come into effect from February 2021. |
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Structured Product Labeling, SPL Software, SPL Format | Freyr SPL | Freyr SPL/SPM tool is an easy to use SPL/SPM Software that manages SPL/Drug listing lifecycle & validates the output as per USFDA regulations with seamless SPL Submissions. |
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Structured Product Monograph, SPM Format, Health Canada | Freyr SPL | Freyr SPM is provides a complete solution for the Health Canada SPM requirements and supports in XML product monograph submissions like NDS, ANDSs, SANDSs, SNDS and all subsequent SPM submissions. |
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SPL software, SPM software, USFDA, Health Canada | Freyr SPL | Freyr SPL/SPM Software is an cost-effective solution for your SPL/SPM submissions which has Automated Process for new SPL/SPM submissions and revisions, adheres with 21 CFR Part 11 HL7 standards. |
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SPL/SPM software quote request, Structured product Labeling/Monograph | Freyr SPL | Request a quote for Freyr SPL/SMM Software, which adheres with 21 CFR Part 11 standards for seamless SPL/SPM submissions to comply with USFDA and Health Canada. |
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SPL/SPM software demo request, Product Monographs | Freyr SPL | Request a Demo for Freyr SPL/SMM software offered in cloud Hosted and on-premise deployment model, which suits all SPL & SPM submission requirements. |
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SPL/SPM Query, SPL/SPM Demo, Software Vendor | Freyr SPL | Freyr Provide the SPL/SPM Software support across entire value-chain with presence in multiple locations like US, Canada, UK, etc. |
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Regulatory Affairs, Regulatory Affairs Consulting Services | Freyr Provides global Regulatory Affairs services to the life science companies for their product development, registration, commercialization and launch of their products across the globe as per regional health Authority regulatory requirements |
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ANDA submissions, Abbreviated New Drug Application, ANDA application, Filing | Freyr provides Regulatory Affairs services to the generic medicinal product companies during ANDA submissions and filing process to explore the shortest route and timeframe to put your products in the market safely, aiming at ultimate commercial success. |
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Biologics License Application, BLA submission, BLA filing, 351(a), 351 (k) | Freyr provides Regulatory Affairs services to the Biologicals/Biosimilars product companies for BLA submission process, starting from pre-BLA meetings, Pre-Market approvals to submission of amendments/supplements, and further Life Cycle Management (LCM) of the various biological products |
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Drug Master File, DMF Submission, DMF filing, USDMF | Freyr provides Regulatory Affairs services during DMF submission and filing with capabilities in managing of DMF (Types II, III & IV) for Drug substances, excipients, and packaging materials to comply with US FDA Freyr provides Regulatory Affairs services during DMF submission and filing with capabilities in managing of DMF (Types II, III & IV) for Drug substances, excipients, and packaging materials to comply with US FDA |
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New Drug Application, NDA submission, NDA filing, 505(b)(1), 505(b)(2), USFDA | Freyr provides Regulatory Affairs services to the innovator medicinal companies for NDA (New Drug Application) filing process, starting from pre-NDA meetings to NDA annual reports submission and further life cycle management of the medicinal Product |
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IND Submission, IND Filing, IND Application, Investigational New Drug, IND Annual Report | Freyr provides Regulatory Affairs service support to the innovator medicinal companies for Investigational New Drug Application (IND) filing process, starting from pre-IND meetings to IND submission and further regulatory compliance & maintenance. |
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Abbreviated New Drug Submission, ANDS Health Canada, ANDS Submission | Freyr provides Regulatory Affairs services to the generic medicinal product companies in Canada to handle generic application submissions (ANDS) to comply with Health Canada for product registration and approval procedures. |
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New Drug Submission, NDS application, Health Canada NDS | Freyr provides Regulatory Affairs services to innovator medicinal product companies in Health Canada New drug submission (NDS) process, starting from pre-NDS meetings to submission of Market Notification and further Life Cycle Management (LCM) activities. |
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Clinical Trial Applications, CTA Application, CTA Submission, CTA Filing | Freyr provides Regulatory Affairs services during planning, preparation and submission of Clinical Trail Applications (CTA) in different countries for different types of medicinal products like small molecules, Recombinant Protein Products, Vaccines, cellular and gene therapy products etc. |
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Regulatory Affairs, Regulatory Needs, Benefits | Freyr provides Regulatory Affairs services to Drugs, Biologics, Cosmetics and Medical Device companies for entire product lifecycle management as per regional health authorities regulatory requirements |
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Clinical Evaluation Report (CER), CE Certification, EU MDR, Europe, Medical devices | Freyr provides regulatory support for medical device manufacturers in preparation of Clinical Evaluation Report (CER), which includes report writing, GAP analysis, Post-market Surveillance(PMS) data support for existing devices and updating Clinical Evaluation Report (CER) as per EU MDR guidelines/regulations. |
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Post Market Surveillance Requirements, EU MDR Post Market Surveillance, medical devices | Freyr provides Post Marketing Surveillance (PMS) support for medical device manufacturers, which includes development of Post-market Surveillance(PMS) strategy, identifying the requirements to meet EU MDR standards, PMS data review, compilation and evaluating the data as per country specific compliance requirements. |
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Performance Evaluation Report (PER), EU IVDR, In Vitro Diagnostic Devices | Freyr helps In-Vitro Diagnostic Device (IVD) manufacturers in Performance Evaluation Report (PER) preparation, development of Performance Evaluation Plan, collecting and assessing the clinical evidence data, review and submission as per EU IVDR regulations for compliant market entry of products in Europe. |
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Medical Device Risk Management Consulting, ISO 14971 Risk Management | Freyr provides ISO 14971 Risk Management consulting services for medical device manufacturers that span across the preparation of comprehensive remediation plan, gap analysis, development of ISO 14971 document and post-Market Surveillance support to ensure the safety and efficacy of medical devices. |
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Design history file, DHF remediation, DHF, Medical devices, USFDA | Freyr provides regulatory support for medical device manufacturers in preparation of Design History File (DHF) document, which include Design Plan, Design verification and validation, Risk Analysis, Design review, hazard identification and Human Factor Analysis to meet US FDA compliance requirements. |
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Device Technical File Publishing, Device technical file, DTF, Medical devices | Freyr provides regulatory support for medical device manufacturers in device technical file publishing, which include creation, review, validation, compilation and device technical file submissions in electronic format to meet country specific health authority regulatory requirements for compliance. |
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Medical Device Labeling, MDR labelling compliance, EUDAMED compliance | Freyr provides end-to-end labeling services for medical device manufacturers that span across label creation, review of IFU (Instructions for Use), Gap analysis, UDI, EUDAMED and EU MDR label compliance support, tracking and maintaining label changes as per the Health Authority regulatory requirements. |
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Medical Device Labeling Requirements, IFU Labeling, UDI compliance | Freyr provides labeling and promotional material regulations support for medical devices manufacturers, which include label creation and review of IFU (Instructions for Use), UDI compliance, GAP analysis, comprehensive artwork check, tracking and maintaining label changes for medical device compliance. |
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Medical device regulatory compliance, GAP analysis, Remediation | Freyr provides medical device regulatory compliance, gap analysis and remediation services for medical device manufacturers that span across UDI, GDPR, EUDAMED compliance support, post approval compliance support, Consultation and representation services for ISO 13485:2016, MDSAP, BGMP and establishment of QMS documents. |
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Medical Device Regulatory Intelligence, Medical Device Market Intelligence | Freyr provides regulatory intelligence services for medical device manufacturers to meet region-specific health authority requirements for compliant market entry of their products and provides comprehensive regulatory Intelligence reports corresponding to organizational needs basing on the region and device type. |
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Best eCTD Software Tool for global eCTD Submissions | Freyr SUBMIT Pro is one of the best eCTD software tool which helps Life science companies in various regulatory submissions to global health Authorities. |
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eCTD publishing Software, eCTD format, eCTD validator | Freyr SUBMIT Pro is an prominent eCTD publishing Software with various features like Inbuilt eCTD validator and viewer, submission tracking, HA query management, rDMS integration and many more. |
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eCTD Submission, eCTD publishing requirement | Freyr SUBMIT Pro is one of the best eCTD Submission software that suits all kinds of Regulatory eCTD publishing and submission requirements across the globe. |
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eCTD Software cost, Request a Demo, eSubmission Software | Freyr SUBMIT Pro is an cloud hosted, on-premise cost effective eCTD submission software with features like eCTD Submission tracker, Viewer, Validation and rDMS Integration. |
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Regulatory Services in Ukraine, MoH, Regulatory affairs consulting | Freyr provides regulatory services and solutions in Ukraine to comply with MoH regulations for pharmaceuticals, medical devices, cosmetics, and food supplements manufacturing companies. |
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Regulatory Services in India, CDSCO, Regulatory affairs consulting | Freyr provides regulatory services and solutions in India to comply with CDSCO regulations for pharmaceuticals, medical devices, cosmetics, and food supplements manufacturing companies. |
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