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
A Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval
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.