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Filing a DMF for Advantia(Tm) Prime with the U.S. FDA

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

  - International Specialty Products

Registrar Corp can help you to properly prepare and submit your Advantia(Tm) Prime DMF to FDA.

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

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

For more information about filing a DMF for Advantia(Tm) Prime, 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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