Pharmaceutical Quality / CMC
Within the CMC area we offer a wide range of services: advice on formulation development and design; organisation of development programs for the drug substance and formulation from the early preclinical phase through the clinical phase to the commercial product based on regulatory knowledge. In addition we can provide project management, creation and compilation of CMC files and contacts with authorities. We have extensive experience of compiling IMPD for application for clinical trials.
For projects approaching an application for marketing authorisation we cooperate with our sister company Scandinavian Regulatory Services (SRS). Please see www.srs.se for more info!