A Drug Master File – or DMF – is a submission to the FDA that provides ‘confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Submitting a Drug Master File is a complex process, and involves the gathering and submission of product-related technical information in an electronic common technical document filing format.
Pragmatic offers a complete solution for all types of original Drug Master Filing, including amendments and Annual Reports. Our comprehensive services cover compilation, review, and technical gap analysis, drawing on over 15 years of experience of supporting companies across the globe.
Fees for DMF filing assistance start from as low as $399. Charges vary based on the nature of services required
Remember: Failure to identify the right starting material or any other mistake may result in failure to pass the GDUFA Complete Assessment. DMF submission should begin with proper planning, to take time to identify the right partner for you.