Submitting a DMF or ASMF to regulatory authorities allows you to securely share proprietary information with your drug product manufacturers without revealing sensitive data to competitors. This not only protects your intellectual property but also facilitates the regulatory review process. We are here to ensure that your submissions meet the stringent standards required for quality and safety, aiding in the smooth approval of your drug applications.
What can we do for you?
- We provide comprehensive assistance in the preparation and submission of DMFs/ASMFs, ensuring that all regulatory requirements are met and that the documentation is complete and accurate.
- Our expert team offers ongoing support to maintain DMFs, including regular updates and amendments to reflect any changes in manufacturing processes, ensuring continued compliance with regulatory standards.
- We facilitate seamless communication with regulatory authorities, addressing any queries or requests for additional information promptly and efficiently.
- Our consultancy services include detailed reviews of existing DMFs to identify and rectify any potential gaps or issues, thereby enhancing the quality and reliability of the files.
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- We offer a complete range of services, including writing, compiling, reviewing, and submitting DMF/ASMF documents to relevant regulatory authorities, as well as handling subsequent queries and updates.
- Our experts are highly experienced with ASMFs for EU countries, the UK, Switzerland and the EMA and DMFs for US, Canada, Australia, China and Japan. In addition, we supported preparing and updating numerous CEP (Certificate of Suitability) dossiers for the European Directorate for the Quality of Medicines & HealthCare (EDQM).