In this insightful episode, hosts Ethan and Desi take you on a deep dive into the drug approval process, emphasizing the critical role of Chemistry, Manufacturing, and Controls (CMC) documentation. With a focus on what sponsors often miss, the discussion highlights how inadequate preparation in key areas like stability studies, process validation, and facility readiness can lead to costly delays or rejections. The episode is packed with actionable advice on how to streamline the submission process, collaborate effectively with Contract Manufacturing Organizations (CMOs), and ensure regulatory compliance to expedite drug approval. Whether you're navigating the NDA or BLA submission process, this episode provides a strategic roadmap to success in drug approvals.

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We are excited to announce the launch of our brand-new podcast, The VirtualPharm: The Regulatory Intelligence Podcast—where we bring Regulatory CMC to life! 🎉

Hosted by industry veterans with decades of experience, The VirtualPharm dives deep into the most pressing and complex topics in Chemistry, Manufacturing, and Controls (CMC). Whether you're navigating the latest FDA regulations, preparing submissions, or tackling intricate compliance challenges, this podcast is your go-to resource for actionable insights and expert guidance.

Why Listen?

• In-Depth Episodes: Explore the latest trends, challenges, and strategies in Regulatory CMC.
• Expert Hosts: Learn from seasoned professionals driving innovation in the biotech and pharmaceutical industries.
• Real-World Solutions: Gain practical advice to help you stay compliant and agile in today’s fast-paced regulatory environment.

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