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Filing a DMF for Color*Additive Concentrates with the U.S. FDA

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

  - Acquos Masterbatch Pty Ltd

Registrar Corp can help you to properly prepare and submit your Color*Additive Concentrates DMF to FDA.

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

  - Format, assemble and deliver your Color*Additive Concentrates DMF to FDA
  - Submit letters of authorization regarding your Color*Additive Concentrates to FDA
 - Provide changes, additions and maintenance of your Color*Additive Concentrates DMF
  - Respond to issues relating to ownership of your Color*Additive Concentrates DMF
  - Assist with submission of responses to FDA concerning your Color*Additive Concentrates DMF
  - Perform any required annual updates for your Color*Additive Concentrates DMF

For more information about filing a DMF for Color*Additive Concentrates, 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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