))
Mastering CMC Quality Module 3 & QOS for NDA Submissions
Manage episode 454750712 series 3603634
Content provided by Despina & Ethan at Enkrisi and Ethan at Enkrisi. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Despina & Ethan at Enkrisi and Ethan at Enkrisi or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
This guide explains how to create a high-quality CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the FDA. It emphasizes the importance of these documents for regulatory compliance, accelerated approval, and demonstrating product quality. The guide provides a step-by-step process, including best practices and common pitfalls to avoid, and highlights the strategic role of the QOS in communicating with regulatory authorities. Ultimately, the text advocates for meticulous preparation and expert consultation to ensure a successful NDA submission. The target audience includes regulatory affairs professionals, CMC scientists, and pharmaceutical executives.
24 episodes
Share
