Human and veterinary medicinal products

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.

• Environmental risk assessment (ERA): In compliance with CVMP/VICH and EMA/CHMP guidelines
• Assessment concepts and testing strategies for registration of veterinary medicinal products: Development of custom solutions under aspects of reliability and economy; waiving possibilities for required tests; discussion of acceptance with the competent authorities
• Study design, performance, and monitoring: To meet all testing requirements in compliance with the relevant guidelines and regulations, in cooperation with other Fraunhofer institutes and also with other experienced testing institutes
• Dossiers on the pharmacological and toxicological properties of active substances: In compliance with regulatory requirements (EU, NTA/CTD)
• Response to complaints: Received from the competent authorities (RMS/CMS) during the registration process