29 Epizód

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

    Közzétéve: 2024. 03. 01.

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

    Közzétéve: 2024. 03. 01.

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

    Közzétéve: 2024. 03. 01.

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

    Közzétéve: 2024. 03. 01.

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

    Közzétéve: 2024. 03. 01.

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

    Közzétéve: 2023. 09. 26.

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

    Közzétéve: 2023. 09. 19.

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

    Közzétéve: 2023. 09. 12.

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

    Közzétéve: 2023. 09. 05.

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

    Közzétéve: 2023. 08. 29.

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

    Közzétéve: 2023. 02. 28.

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

    Közzétéve: 2023. 02. 21.

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

    Közzétéve: 2023. 02. 14.

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

    Közzétéve: 2023. 02. 07.

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

    Közzétéve: 2023. 01. 31.

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

    Közzétéve: 2023. 01. 24.

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

    Közzétéve: 2022. 12. 14.

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

    Közzétéve: 2022. 12. 07.

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

    Közzétéve: 2022. 11. 30.

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

    Közzétéve: 2022. 11. 23.

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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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