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|
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
QARA Annual Activities
|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.