Services to Ease FDA Regulatory Compliance

DRUG MASTER FILE SUBMISSION

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

Why choose Pragmatic for DMF Submission?
  • We have more than 15 years’ experience of filing DMF Submissions.
  • Our assure client confidentiality
  • We provide in-depth technical knowledge on all functional areas
  • We offer a complete solution, from a gap analysis of technical documentation, review and compilation in eCTD format to the submission through ESG.
  • We support you until receive an acknowledgement letter or a complete technical evaluation of your DMF.
  • We bring expertise in the evaluation of chemistry, manufacturing and control information.
  • We offer guidance on the FDA general regulatory compliance requirements, including US Agent, Establishment registration, Labeler code, and NDC number listing.
  • We respond promptly to all your questions, and don’t charge extra for the service.

If you have questions, please visit our FAQ section. Alternatively, you can contact us.

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.

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