Whitepaper: CMC regulatory landscape, cell and gene therapy products
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
Like all biotech products, getting life-saving medicines to market quickly can be delayed if you’re not prepared for regulatory inspections. Whether you’re a large or new and emerging biotech company, many companies find themselves lacking the internal resources and/or expertise to properly support regulatory filings.
Learn more about:
- Unique attributes of viral vector products
- Clinical and regulatory landscape for cell and gene therapies
- Regulatory and CMC challenges.
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Biologics, Biopharmaceuticals, Drug Delivery Systems, Excipients, Formulation, Freeze Drying, Gene therapy, Good Manufacturing Practice (GMP), Ingredients, Manufacturing, Microbiology, Outsourcing, Packaging, QA/QC, Regulation & Legislation, Research & Development (R&D), Stem Cells, Supply Chain, Vaccines