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Filing a DMF for Hard Pack with the U.S. FDA

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

  - Showa Denko Packaging Corporation

Registrar Corp can help you to properly prepare and submit your Hard Pack DMF to FDA.

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

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

For more information about filing a DMF for Hard Pack, 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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