29 Episoder

  1. Season 5: Episode 5 – Reporting Adverse Events Under MoCRA

    Publisert: 1.3.2024

  2. Season 5: Episode 4 – Safety in Focus – MoCRA Safety Substantiation

    Publisert: 1.3.2024

  3. Season 5: Episode 3 – Mastering Product Listing: A Comprehensive Guide to MoCRA Requirements

    Publisert: 1.3.2024

  4. Season 5: Episode 2 – Untangling the Responsibilities of MoCRA Agents and RPs

    Publisert: 1.3.2024

  5. Season 5: Episode 1 – MoCRA Facility Registration: What You Need to Know?

    Publisert: 1.3.2024

  6. Season 4: Episode 5 - Key Considerations for Comparative Quality Studies for the Proposed Biosimilar Product in EU

    Publisert: 26.9.2023

  7. Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars

    Publisert: 19.9.2023

  8. Season 4: Episode 3 - CMC Requirements for Biologics/Biosimilars

    Publisert: 12.9.2023

  9. Season 4: Episode 2 - ICH Guidelines for CMC Development of Biologics/Biosimilars

    Publisert: 5.9.2023

  10. Season 4: Episode 1 - Introduction to Biologics/Biosimilars and Regulatory Pathways for Approval in the EU

    Publisert: 29.8.2023

  11. Season 3: Episode 6 - Regulatory Lifecycle Management of Medicinal Products

    Publisert: 28.2.2023

  12. Season 3: Episode 5 - Medicinal Products’ Intellectual Patenting

    Publisert: 21.2.2023

  13. Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance

    Publisert: 14.2.2023

  14. Season 3: Episode 3 - Procedures for Medicinal Products’ Approval

    Publisert: 7.2.2023

  15. Season 3: Episode 2 - GDUFA & PDUFA Guidelines

    Publisert: 31.1.2023

  16. Season 3: Episode 1 - US Market Entry & Landscape In Regulatory Affairs

    Publisert: 24.1.2023

  17. Season 2: Episode 6 - Pharma Advertising and Promotions: Canada

    Publisert: 14.12.2022

  18. Season 2: Episode 5 - Pharma Advertising and Promotions: Mexico

    Publisert: 7.12.2022

  19. Season 2: Episode 4 - Pharma Advertising and Promotions: United Kingdom

    Publisert: 30.11.2022

  20. Season 2: Episode 3 - Pharma Advertising and Promotions: Lithuania

    Publisert: 23.11.2022

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Freyr is a leading, niche, full-service global Regulatory Solutions, and Services Company supporting, Large, Medium, and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Food and Food Supplements | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions.

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