• Mastering the Art of Authoring a CMC Quality Module 3 and QOS for an NDA: A Simple Guide

  • Nov 5 2024
  • Length: 12 mins
  • Podcast

Mastering the Art of Authoring a CMC Quality Module 3 and QOS for an NDA: A Simple Guide

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  • Summary

  • 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.

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