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Home U.S. FDA Drug Regulations › U.S. FDA Drug Master File (DMF)

U.S. FDA Drug Master File Requirements

Drug companies can submit a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information in support of a submission to FDA without disclosing the information to anyone other than FDA.

FDA requires all DMF submissions to be in electronic common technical document (eCTD) format beginning May 5, 2018.

Registrar Corp assists with eCTD requirements. Our Regulatory Specialists will:
Drug Master File Certificates Issued By Registrar Corp
  • File a new DMF with U.S. FDA in eCTD
  • Update or Amend an existing DMF with U.S. FDA
  • Convert existing DMFs to eCTD
  • Serve as your Agent for U.S. FDA Communications
  • Reactivate inactive DMFs with U.S. FDA and convert them to eCTD

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

 I would like to file a new DMF with U.S. FDA
 I would like to convert an existing paper DMF to eCTD
 I would like to amend or update an existing DMF with U.S. FDA
Company Name: *
Contact Person Name: *
Physical Address: *
City: *
Country: *
Postal Code:
Phone: *
E-mail: *
* is required

U.S. FDA Regulations:

U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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