Ask the Experts: Navigating FDA & EMA CMC Expectations for Cell and Gene Therapy Product Development
Published on: Mar 14th, 2025
During the session, our CMC regulatory experts shared firsthand insights on FDA and EMA expectations for cell and gene therapy (CGT) product development. Drawing from extensive experience across multiple projects and direct interactions with regulatory agencies, they discussed key feedback trends, common challenges, and best practices for a smooth regulatory pathway.
In this Ask the Expert session, we answered questions concerning topics such as:
- How do FDA and EMA expectations differ for CGT CMC requirements?
- How should companies approach regulatory interactions to optimize feedback?
- What are the key elements of a robust CMC strategy for early-stage development?
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