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.