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Streamlining Regulatory Compliance for AAV-Based Gene Therapies
Novel AAV vector design and capsid engineering carries important considerations throughout development, therefore a multidisciplinary approach must be undertaken to ensure regulatory approvals. Learn more about the regulatory pain points for developers and manufacturers and discover tips for meeting regulatory guidance for AAV-based gene therapies. Read this article to learn:
- When to talk to the regulatory teams
- The role of change management
- How to leverage collaboration across companies to solve challenges
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