DMF Compilation & Submissions

The Drug Master File (DMF) is a document submitted to regulatory authorities by pharmaceutical companies to provide confidential, detailed information about a specific aspect of a drug substance, drug substance intermediate, or excipient that is used in the manufacturing of a drug product. The information contained in a DMF is considered confidential and is protected under regulations in the US and EU.

A DMF compilation is the process of collecting and organizing the information that is required to be included in the DMF. This information includes details such as the chemical and physical properties of the drug substance, manufacturing processes, quality control procedures, and stability data.

DMF submission is the process of submitting the completed DMF document to the relevant regulatory authority for review and approval. The purpose of the submission is to provide information about the drug substance to support the approval of a drug product that contains it. The submission process may include additional rounds of review and communication with the regulatory authority, as well as the provision of additional information or clarification as needed.

With over 15+ years experience, our regulatory affairs team has helped several pharma and medical device companies in compiling and submitting the DMF with the following principles:

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How We Can Help

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DMF Compilation

At Techsol, we have a specialized team who can help to streamline the DMF compilation and submission process, reducing the time and resources required to complete the process and increasing the chances of a successful outcome. 

Our team can provide end-to-end support for preparing the following types of Drug Master Files:

>  Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product

>  Type III Packaging Material

>  Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

>  Type V FDA-Accepted Reference Information

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