Occams

Occams provides services in the field of preparation and/or review of documentation for regulatory submissions, and interaction with health authorities in matters relating to PK, PK/PD and modelling and simulation. We also have considerable experience with acting as the regulatory representative for clinical pharmacology during mock advisory board meetings. We have many years of experience both within the regulatory arena and interacting with regulatory agencies from both academic and industrial perspectives. This makes us uniquely qualified to help our clients maximise the utility of model-based analyses with respect to gaining marketing approval.