The heavily regulated market of medicinal products and medical devices requires approvals and maintenance activities for the manufacturing, clinical trials, marketing authorisations, renewals and regulatory maintenance activities.
Long-term experience and competence of professionals in Regulatory Sciences (International Regulatory Affairs, Product & Device Approvals, Pharmacovigilance & Drug Safety, Regulatory Compliance: GMP, GLP, GCP) effectively supports the regulatory life cycle management of medicinal products and medical devices.
Early and continuous consultation on regulatory requirements and strategies contributes substantially to the success of Research and Development (R&D) projects of pharmaceutical manufacturers.
With a network of globally operating partners we can offer comprehensive services in Europe, Japan and the USA.
