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
Mastering the Art of Authoring a CMC Quality Module 3 and QOS for an NDA: A Simple Guide
This Podcast is a guide to authoring a successful CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the Food and Drug Administration (FDA). Ethan and Desi detail the importance of these documents for demonstrating a product's quality, navigating the regulatory review process, and achieving global market access. They also provides best practices for authoring these documents, common pitfalls to avoid, and strategic advice for optimizing their use. The discussion emphasizes the QOS as a critical component for communicating with regulatory authorities and justifying deviations from standard guidelines, thus streamlining the review process.