The VirtualPharm
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
The VirtualPharm
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.