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Filing a DMF for Transcutol with the U.S. FDA

Filing a drug master file (DMF) for Transcutol can be a useful mechanism to market your Transcutol to the U.S. Drug Industry. Typical Transcutol producers who have filed a DMF for Transcutol include:

  - Gattefosse Establissements

Registrar Corp can help you to properly prepare and submit your Transcutol DMF to FDA.

As your Agent, Registrar Corp will perform the following administrative functions:

  - Format, assemble and deliver your Transcutol DMF to FDA
  - Submit letters of authorization regarding your Transcutol to FDA
 - Provide changes, additions and maintenance of your Transcutol DMF
  - Respond to issues relating to ownership of your Transcutol DMF
  - Assist with submission of responses to FDA concerning your Transcutol DMF
  - Perform any required annual updates for your Transcutol DMF

For more information about filing a DMF for Transcutol, simply click below:




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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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