For a well-defined active substance, the active substance manufacturer or the applicant for new drug approval may arrange for the:
- Detailed description of the manufacturing process
- Quality control during the manufacturing process
- Process validation
To be supplied in a separate document directly to the competent authorities by the manufacturer of the active substance. In Europe this is referred to as an Active Substance Master File (ASMF). In the USA it is called a Drug Master File (DMF). This document allows the Active substance manufacturer to keep his intellectual property confidential. There is no requirement by law or regulation to present a DMF/ASMF. However, authorities have been placing a greater scrutiny on their organization and content as they are reviewed in conjunction with Investigational New Drug Applications (IND), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Export Applications, and/or amendments and supplements to any of these.
We believe that we can help you realize savings on the cost of creating, maintaining and updating your DMF/ASMF while you benefit from our resources and the timeliness of our services. We offer the following services:
- Filing Letters of Authorization
- Maintaining Customer List
- Creating your DMF/ASMF
- Annual Updates to DMF
If you would like more information, get in contact with us directly here.