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What the FDA Demands in Your Drug Master File

April 29, 2020

Select a video from the collection below:

Drug Master File Part I: Introduction & Purpose

Drug Master File Part II: US DMF Process

Drug Master File Part III: Content of a DMF

Drug Master File Part IV: Items to Consider

Drug Master File Part V: Maintenance of Your DMF

The Drug Master File (DMF) is a great tool to file you proprietary technology with the FDA while authorizing customers to reference your DMF.

This Video Covers:

  • Overview/Purpose of CMC/DMF
  • US DMF Process
  • Content of Type II US DMF
  • Items to Consider in the Preparation of US DMF
    Synthesis Development and Validation
    Analytical Development and Validation
    Impurity identification
    Stability
    Raw Material Supply
  • Maintenance of DMF
  • Ex-US DMF Overview
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