DMF Services

At Pragya Dossier-DMF Services, we specialize in providing comprehensive Drug Master File (DMF) services in the Common Technical Document (CTD) format, designed to meet the regulatory requirements of global markets. Our expert team ensures that your DMF submissions are meticulously prepared, well-organized, and compliant with the latest industry standards.

Our DMF Services Include:

• CTD Format Preparation: We craft DMFs in the CTD format, ensuring that each section is detailed and precise, reflecting the highest level of quality and compliance.

• Regulatory Strategy: Our services include regulatory strategy consulting to optimize your submission process and enhance the likelihood of successful approval.

• Technical Writing & Compilation: We provide expert technical writing services to accurately present complex data, ensuring clarity and adherence to regulatory guidelines.

• Gap Analysis & Review: Our team conducts thorough gap analyses and reviews to identify and rectify any deficiencies in your DMF before submission.

• Lifecycle Management: We offer ongoing support for the maintenance and updating of your DMFs to comply with evolving regulatory requirements.

Our team of experts will be happy to assist you. PDDS write (prepare / Draft) and review DMF as per CTD Guideline; We do Open and Closed Part of DMF (both / single - as per client requirement)

Format : CTD (Common Technical Document)

Table of content

• CTD Introduction

• Quality Overall Summary

• S.1 General Information

• S.2 Manufacture (ROS)

• S.3 Characterization

• S.4 Control of Drug Substance

• S.5 Reference Standards or Materials

• S.6 Container Closure System

• S.7 Stability

With Pragya Dossier-DMF Services, you can be confident that your DMF submissions are in capable hands, allowing you to focus on your core business while we manage the intricacies of regulatory compliance.

Contact Us today to learn more about how we can support your DMF needs in the CTD format.