Services to Ease FDA Regulatory Compliance

FAQ: DRUG MASTER FILE

How much is the DMF Fee and when should I pay?

For 2017, the FDA DMF fees  are $51,140. This fee should be paid well before referencing your DMF in your ANDA application. It means you can still submit the DMF to FDA without paying the fees and wait for the  ANDA sponsor.

How much time is required for DMF submission?

The timeline for the DMF submission depends on the availability of technical documents. If you have all the documents – including Batch records, Specification, Method of analysis, In process specification, Raw material specification and testing reports, Impurity profiling, Batch analysis data, and stability study – it will take about 10 working days to compile the … Continue reading How much time is required for DMF submission?

How we can assist for DMF submission to FDA?

Pragmatic offers a complete solution for all types of DMF submission to the FDA. We offer DMF review, compilation, technical gap analysis, eCTD conversion and submission through ESG. We also provide services for management throughout the lifecycle of a drug master file. Please contact us for more information.

What is a Drug Master File?

A Drug Master File – or DMF – is FDA’s provision to submit confidentiality information on the chemistry, manufacturing and control information about a product for the agency’s evaluation.

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