Regulatory Affairs

Medical Research Laboratory: Portrait of Female Scientist Working on Computer Showing MRI Brain Scans.

Our team of regulatory experts offers consulting and management within all aspects of product development from quality/CMC and preclinical to clinical development, as well as medical devices.

We provide consultancy, management and support for submissions to competent authorities, ethics committees and radiation safety authorities, as well as conformity assessments for medical devices. We manage and support scientific advice procedures, as well as correspondence with regulatory authorities, with advice and documents according to current guidelines and regulations. This is done in cooperation with our project managers, CRAs and CTAs who are responsible for the operational part of the submissions.