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Filing a DMF for Kollicoat(R) IR White with the U.S. FDA

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

  - BASF Aktiengesellschaft

Registrar Corp can help you to properly prepare and submit your Kollicoat(R) IR White DMF to FDA.

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

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

For more information about filing a DMF for Kollicoat(R) IR White, 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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