US FDA Drug Master File





A Drug Master File submitted to any country regulatory authority should contains confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drugs. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements without disclosure of processing details.

Drug Master File (DMF) submitted to US FDA may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these.

The Drug Master File contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.

QARA Provide DMF Submission guidance to United States Food and Drug Administration

   
Type II Drug Substance, Drug Substance Intermediate, and Material Used in their Preparation, or Drug Product
Type IIIPackaging Materials

THE NEW, SIMPLE WAY TO GET US DMF NUMBER FOR TYPE II AND TYPE III ONLINE.

Online application, fee payment and cloud document storage facility makes the process three times faster than others.

QARA online documentation team will work for you to prepare submission documents, which makes the process faster ( less than 45 days)

No matter where you are OR where we are....

Contact us to get started.





 

 

How QARA can help you in US DMF Submission


  • Suitability of documents submitted by client including process documents and test reports
  • Request additional documents from client
  • Provide a checklist containing documents to be provided by client to consultant for the DMF Preparation.
  • Preparation of Drug Master Submission File by QARA Consultants.
  • Design File to accommodate multiple items in same submission in eCTD
  • Edit and organize DMF information as per FDA required format.
  • Navigation Aid Management including the table of contents and hyperlinks
  • Communicating with FDA on behalf of our client.
  • Assisting clients to issue LOA (letter of authorization) to FDA.
  • Guidance on GMP

 

 

QARA Annual Activities


  • Respond to FDA concerns about Drug Master File submitted by client
  • Inform DMF changes, additions, and deletions to the FDA
  • Letters of authorization to the FDA.
  • Closure of a DMF on file with the U.S. FDA, as required
  • Annual report submission to FDA
  • DMF Closure request submission to FDA
  • DMF Reactivation request submission to FDA. (for closed DMF)

 

DMF Type Description No of Days Fee
Type II Verification of Documents submitted by client 5 Days $ 949
OR       Drug Master File Complete Preparation 45 Days $ 3549 - $ 4549
 
Type III Verification of Documents submitted by client 5 Days $ 749
OR        Drug Master File Complete Preparation 45 Days $ 2499 - 2949
 
Type II & III US Agent Service 7 Days $ 649 Annually

 

 

Payments

All payments to be made to I 3 Consulting as per the details mentioned in invoice.

Payments in 4 equal installments.

 

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