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Master File Assistance

Companies can submit a Drug Master File (DMF), Medical Device Master File (MAF), or Veterinary Master File (VMF) to the U.S. Food and Drug Administration (FDA) and Health Canada to provide confidential information about facilities, processes, or articles.  A Master File holder can authorize others to use information within the submission to support drug applications or premarket submissions without disclosing trade secrets to industry.

Registrar Corp assists with FDA and Health Canada Master Files.  Our Regulatory Specialists can:

  • File a new DMF, MAF, or VMF
  • Update or Amend an MF with U.S. FDA or Health Canada
  • Convert a paper DMF to eCTD

For assistance with FDA or Health Canada Master Files, simply complete the form below: