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 III	Packaging 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....

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
Type II	OR Drug Master File Complete Preparation	45 Days	$ 3549 - $ 4549

Type III	Verification of Documents submitted by client	5 Days	$ 749
Type III	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.

enquiry@i3cglobal.com