Regulatory & Consultancy

CMC Dossiers

The dossier team at Arcinova have the knowledge and experience to advise on the CMC content of clinical trial applications and/or to prepare the CMC aspects of these applications directly from the relevant source data. This service can be accessed on a stand-alone basis or as part of an integrated Arcinova CMC service. This service is also provided for clinical trials designed to study the absorption, metabolism and excretion of pharmaceuticals which have been radiolabelled.