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.
https://freyrsolutions.podbean.com
Gesamtlänge aller Episoden: 4 hours 18 minutes
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episode 1: Season 4: Episode 1 - Introduction to Biologics/Biosimilars and Regulatory Pathways for Approval in the EU
Introduction to Biologics and Biosimilars is the core of this episode. Our Regulatory experts will give an overview of the different Regulatory approval pathways for Biologics and Biosimilars in the EU. Additionally, they will discuss the significanc...
episode 3: Season 4: Episode 3 - CMC Requirements for Biologics/Biosimilars
Our experts will also share insights on the steps involved in the characterization of biological products, expression systems, and related details.
episode 4: Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars
This episode will discuss the challenges faced during complex biological product development.
episode 5: Season 4: Episode 5 - Key Considerations for Comparative Quality Studies for the Proposed Biosimilar Product in EU
In the last episode of Freyr Regulatory Radio, Season 4, our experts discuss key considerations for Comparative Quality Studies for a proposed biosimilar product in the EU.
episode 8: Season 4: Episode 2 - ICH Guidelines for CMC Development of Biologics/Biosimilars
Episode 2 will detail the various guidelines for biological product development and approval in the market.
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