Chemistry, Manufacturing and Control (CMC) is part of the regulatory file that deals with the characterization of an API (chemistry), its production (manufacturing) as well as the reliability and reproducibility (control) of the produced batches. At Syntagon, we closely monitor changes in regulatory requirements and incorporate these new principles in a timely fashion. We will keep you updated and work proactively with you to make sure that the CMC file will pass even the most stringent reviews.
Syntagon compiles all relevant information in a format ready for the CMC dossier – both in US (IND) and EU (IMPD) formats. Based on our extensive experience, we will propose a level of information appropriate for the intended stage of trials. This allows us to streamline the process so that our document compilation – and your compound’s approval – is certain to avoid any unnecessary delays.