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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