DMF (Drug Master Files)
US Drug Master Files (DMFs) is a submission to the US FDA the confidential information about facilities, processes or components used in the manufacturing, processing, packaging and storing of one or more human drugs.
Our experts will guide you the entire process, prepare, edit and submit through our US Agent.
- Arrange and guide in supporting Documentation.
- Guidance on Chemistry, Manufacturing, and Controls.
- Identification of test requirement.
- Edit and organize information.
- Appointing the US Agent.
- Submit to FDA.
- Inform changes to FDA.
- Annual report submission.
- Communicating with FDA on behalf of our client.
- Assisting clients to issue LOA (letter of authorization).
- Current Good Manufacturing assessment (GMP GAP Analysis).
- Environmental assessment as per 21 CFR part 25.
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