What the FDA Demands in Your Drug Master File

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