Manufacturers of APIs are facing more and more hard competition in a global market. At the same time, they have to open product and process know-how to convince customers and authorities about the quality of their processes. To do so, while keeping the know-how confident, they have the chance to provide this sensitive information in special documents to the authority – Drug Master Files in the US, Active Substance Master Files and Certificates of Suitability with the EP monograph in the EU. Those documents must be created accurately with all necessary details and following strict regulations on content and format.
DMF, ASMF and CEP service provides the support in the creation and filing of related documents following all regulatory requirements to finally receive approval.
When to create DMF, ASMF and/or CEP?
Those documents are needed for the registration of the final drug product, the API is used in. You can create when having all date (e.g. stability data) in hand. Which document depends on the target market and the target product. We provide consultancy on which is the best choice.
What are detailed requirements on format and content?
There is an international guideline providing a fixed structure known as CTD (Common Technical Document). It defines in details the table of content. Additional guidelines need to be considered dependent whether application will be made in the US or the EU. gempex experts are familiar with all those guidelines.
How to know, which information to provide and how?
Before creating the document, we always will do at least one intensive training to provide the needed knowledge to the involved persons to show, which data to collect, how to summarize and evaluate and how to prepare for the document.
How can we be sure about the final quality?
We have close cooperation with high-level experts in the EU as well as in the US. In case you are not confident about the quality and completeness of the data, those experts will do a final expert review before filing to authority.
gempex China offers professional service and support in the preparation of ASMF, CEP and/ or DMF documents including but not limited to training, filing and authority communication.
- time saving and thus marketing acceleration
- thoughtful advice and consultancy during document creation
- assurance of compliance of the final documents
- DMF document number or CEP certification