What the FDA Demands in Your Drug Master File
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