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|
All payments to be made to I 3 Consulting as per the details mentioned in invoice.
Payments in 4 equal installments.