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Specializing in FDA Regulatory Matters

Drug Master Files

Drug Master Files (DMF) are submissions to the FDA which allow the holder to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing without providing proprietary information to their customers.

While not required by law, the information contained within a DMF may be used to support applications such as Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.

EAS Consulting Group files DMFs on behalf of clients, ensuring information is complete and accurate and that all FDA requirements are met. EAS can also provide support for any required annual updates to FDA.

Of interest to foreign firms, FDA strongly encourages foreign firms to use U.S. Agents for the filing of their DMFs to ensure accuracy as well as expedited administrative acceptability due to familiarization with FDA laws and regulations. EAS can serve as the appointed U.S. Agent on the DMF.