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File U.S. FDA Drug Master Files in eCTD

As of May 5, 2018, FDA requires electronic common technical document (eCTD) format for Type II, Type IV, and Type V drug master file (DMF) submissions, including reports, amendments, and supplements.  FDA states that it will reject non-eCTD DMF submissions of these types.  Registrar Corp can submit documentation in eCTD to FDA on your behalf.

For assistance with FDA DMF eCTD requirements, simply complete the form below:





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