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Filing a DMF for Primer PR-109 with the U.S. FDA

Filing a drug master file (DMF) for Primer PR-109 can be a useful mechanism to market your Primer PR-109 to the U.S. Drug Industry. Typical Primer PR-109 producers who have filed a DMF for Primer PR-109 include:

  - Coim USA Inc

Registrar Corp can help you to properly prepare and submit your Primer PR-109 DMF to FDA.

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

  - Format, assemble and deliver your Primer PR-109 DMF to FDA
  - Submit letters of authorization regarding your Primer PR-109 to FDA
 - Provide changes, additions and maintenance of your Primer PR-109 DMF
  - Respond to issues relating to ownership of your Primer PR-109 DMF
  - Assist with submission of responses to FDA concerning your Primer PR-109 DMF
  - Perform any required annual updates for your Primer PR-109 DMF

For more information about filing a DMF for Primer PR-109, 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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