Full documentation to support your clinical trial and authorization process

Drug Master Files, full CMC documentation, close cooperation with CROs 

For your clinical trial documentation, we will provide you with the necessary information. In many cases we will establish a drug master file (DMF) or an active substance master file (ASMF). If a DMF or ASMF is not required, we provide you with the CMC documentation which comprises all the information about the synthesis and quality control of a precursor and the reference standards that can build the basis for your IMPD and later for your marketing authorization application.