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Filing a DMF for MDI Counter Project with the U.S. FDA

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

  - Mikron Ag Biel

Registrar Corp can help you to properly prepare and submit your MDI Counter Project DMF to FDA.

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

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

For more information about filing a DMF for MDI Counter Project, 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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