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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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. The reference guidelines discussed in the podcast will include the following:
- Guidelines that describe the expression construct, cloning, cell bank preparation, and characterization of biological products.
- Guidelines to be referred for biologics drug substance development and manufacturing.
- Guidelines to be referred for viral safety evaluation and analytical method validation of the products.
- Stability management of biological products.
Our Regulatory experts will share more details about the subsidiary guidelines to be referred by a pharma company for streamlining Biologics development.