File U.S. FDA Drug Master Files in eCTD
As of May 5, 2018, FDA will require 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: