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