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

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 significance and requirements of Regulatory submissions and scientific advice during the Regulatory processes.

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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.