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Filing a DMF for Pharmaburst(Tm) C1 with the U.S. FDA

Filing a drug master file (DMF) for Pharmaburst(Tm) C1 can be a useful mechanism to market your Pharmaburst(Tm) C1 to the U.S. Drug Industry. Typical Pharmaburst(Tm) C1 producers who have filed a DMF for Pharmaburst(Tm) C1 include:

  - Spi Pharma

Registrar Corp can help you to properly prepare and submit your Pharmaburst(Tm) C1 DMF to FDA.

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

  - Format, assemble and deliver your Pharmaburst(Tm) C1 DMF to FDA
  - Submit letters of authorization regarding your Pharmaburst(Tm) C1 to FDA
 - Provide changes, additions and maintenance of your Pharmaburst(Tm) C1 DMF
  - Respond to issues relating to ownership of your Pharmaburst(Tm) C1 DMF
  - Assist with submission of responses to FDA concerning your Pharmaburst(Tm) C1 DMF
  - Perform any required annual updates for your Pharmaburst(Tm) C1 DMF

For more information about filing a DMF for Pharmaburst(Tm) C1, 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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