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Filing a DMF for Pharmaburst(Tm) B Series Products with the U.S. FDA

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

  - Spi Pharma

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

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

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

For more information about filing a DMF for Pharmaburst(Tm) B Series Products, 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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