CMC Regulatory for Early Drug Development Success

Cracking the Code

CMC Regulatory Compliance in Early Drug Development

Summary

This two-part blog post and podcast series provides a guide for small biotech companies on navigating Chemistry, Manufacturing, and Controls (CMC) regulatory compliance during drug development. It emphasizes the importance of strategic CMC planning, risk assessment, and early engagement with regulatory authorities from Phase 1 through Phase 3 clinical trials. The series stresses the critical role of CMC in ensuring product quality and safety, highlighting the benefits of prior initiatives such as the Quality by Design (QbD) approach. The first part focuses on early-stage development, while the second part (not included here) will cover the transition to market. Ultimately, the goal is to help biotech companies successfully bring new therapies to market. Stay tuned for Part two where we focus on Later Phase 2 and Phase 3 planning later this Winter.

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