Filing a drug master file (DMF) for Colorant can be a useful mechanism to market your
Colorant to the U.S. Drug Industry. Typical Colorant producers who have filed a DMF for
National Plastics Color Inc
Registrar Corp can help you to properly prepare and submit your Colorant DMF to FDA.
As your Agent, Registrar Corp will perform the following administrative functions:
Format, assemble and deliver your Colorant DMF to FDA
Submit letters of authorization regarding your Colorant to FDA
Provide changes, additions and maintenance of your Colorant DMF
Respond to issues relating to ownership of your Colorant DMF
Assist with submission of responses to FDA concerning your Colorant DMF
Perform any required annual updates for your Colorant DMF
For more information about filing a DMF for Colorant, simply click below:
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.