Freyr Regulatory Radio
A podcast by Freyr Solutions
29 Episodes
-
Season 5: Episode 5 – Reporting Adverse Events Under MoCRA
Published: 01/03/2024 -
Season 5: Episode 4 – Safety in Focus – MoCRA Safety Substantiation
Published: 01/03/2024 -
Season 5: Episode 3 – Mastering Product Listing: A Comprehensive Guide to MoCRA Requirements
Published: 01/03/2024 -
Season 5: Episode 2 – Untangling the Responsibilities of MoCRA Agents and RPs
Published: 01/03/2024 -
Season 5: Episode 1 – MoCRA Facility Registration: What You Need to Know?
Published: 01/03/2024 -
Season 4: Episode 5 - Key Considerations for Comparative Quality Studies for the Proposed Biosimilar Product in EU
Published: 26/09/2023 -
Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars
Published: 19/09/2023 -
Season 4: Episode 3 - CMC Requirements for Biologics/Biosimilars
Published: 12/09/2023 -
Season 4: Episode 2 - ICH Guidelines for CMC Development of Biologics/Biosimilars
Published: 05/09/2023 -
Season 4: Episode 1 - Introduction to Biologics/Biosimilars and Regulatory Pathways for Approval in the EU
Published: 29/08/2023 -
Season 3: Episode 6 - Regulatory Lifecycle Management of Medicinal Products
Published: 28/02/2023 -
Season 3: Episode 5 - Medicinal Products’ Intellectual Patenting
Published: 21/02/2023 -
Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance
Published: 14/02/2023 -
Season 3: Episode 3 - Procedures for Medicinal Products’ Approval
Published: 07/02/2023 -
Season 3: Episode 2 - GDUFA & PDUFA Guidelines
Published: 31/01/2023 -
Season 3: Episode 1 - US Market Entry & Landscape In Regulatory Affairs
Published: 24/01/2023 -
Season 2: Episode 6 - Pharma Advertising and Promotions: Canada
Published: 14/12/2022 -
Season 2: Episode 5 - Pharma Advertising and Promotions: Mexico
Published: 07/12/2022 -
Season 2: Episode 4 - Pharma Advertising and Promotions: United Kingdom
Published: 30/11/2022 -
Season 2: Episode 3 - Pharma Advertising and Promotions: Lithuania
Published: 23/11/2022
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.