Any medicinal product intended for the European market requires approval by the authorities (national authorization or de-/centralized authorization by the European Commission). Our Department of Risk Assessment has many years of experience in this domain. We evaluate the necessary data on behalf of clients from the pharmaceutical industry and prepare dossiers in compliance with the regulatory requirements.
An important part of medicinal product registration is the assessment of potential environmental risks. Because of the relatively new requirements to be met in environmental risk assessment of a pharmaceutical, many questions arise that can also not be fully answered by the existing guidelines and general EU assessment concepts. We have extensive experience in this domain, not only in the preparation of the necessary documents, but also in the successful development of customized testing strategies including related discussions with the competent authorities. Additional experimental investigations that may be required can be performed by Fraunhofer institutes or other experienced testing institutes.