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

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

  - BASF SE

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

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

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

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