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Filing a DMF for Pancogene(R) Marin with the U.S. FDA

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

  - Gatefosse Sa

Registrar Corp can help you to properly prepare and submit your Pancogene(R) Marin DMF to FDA.

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

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

For more information about filing a DMF for Pancogene(R) Marin, 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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