Benefit from our expertise resulting from numerous authorisation procedures for medicinal products with chemically defined active substances, phytopharmaceuticals and biologicals, carried out either in conjunction with our customers or independently on their behalf.
We will prepare the necessary applications and dossiers for the clinical trial and the marketing authorisation in CTD format, either in whole or in part. Regardless of the active substance and mode of administration, we will guide you effectively through the national or regional authorisation procedure. We are also happy to take care of communication with the authorities and project management in the authorisation procedure for you. The current regulatory requirements and your individual needs are of course considered.