Fraunhofer Institute for Toxicology and Experimental Medicine

Regulatory research and risk assessment in drug development

Evaluating and assessing the risks and benefits of innovative medicinal products

Fraunhofer ITEM has combined its expertise in drug research and development with its experience in registration and risk assessment of chemicals. With these forces joined, the institute is uniquely positioned to support clients in regulatory affairs in the drug development process. Our scientists explore, develop, and validate new approaches to manufacture, characterize, and test innovative medicinal products, ensure regulatory input on these approaches, and implement them in product development in cooperation with the client.

Our expertise allows experimental studies for risk assessment and registration of substances to be goal-oriented and focused on what is really needed. We support our clients in regulatory affairs and risk assessment.

Our services and expertise

Regulatory Strategy from the Lab to Market and Coordination with Regulatory Authorities

We support you in reliably developing innovative products from the lab through to regulatory approval. To this end, we develop a tailored regulatory strategy, plan the project steps relevant to regulatory requirements, and coordinate the necessary R&D disciplines.

We facilitate coordination with national and international authorities such as the EMA and FDA through scientific and regulatory advice, e.g. regarding clinical trials, ATMP classification, or orphan drug status. For regulatory issues, deficiencies, or additional requirements, we provide scientifically sound solutions, expert opinions, overviews, and analyses.

ICH M7 – Assessment of Mutagenic Impurities and Regulatory Support

Mutagenic impurities can pose significant regulatory challenges throughout pharmaceutical development.

Fraunhofer ITEM provides comprehensive support with science-based testing strategies, genotoxicity studies, and robust risk assessments in accordance with ICH M7 – from initial hazard evaluation to regulatory submission and documentation.

ERA for marketing authorisation of veterinary and human medicinal products

Pharmaceuticals that are to be marketed in Europe must always seek marketing authorisation by the competent authorities. The environmental risk assessment (ERA) is an important part marketing authorisation application (MAA) dossier.

For our clients in the pharmaceutical industry, we evaluate the necessary data, draw up the ERA for the application in line with the regulatory requirements and provide support with compiling all the required documentation, developing suitable testing strategies and engaging in discussions with the competent authorities.

Environmental risk assessment

Regulatory research

Development of innovative tools, standards, and methodologies for the evaluation of pharmaceuticals (safety, efficacy, quality, and therapeutic benefit)
Research across the critical path of drug development, from safety assessment and demonstration of clinical benefit to product industrialization

Your benefit

Regulatory research and risk assessment in drug development — © Fraunhofer ITEM, Ralf Mohr

We act as interface between clients and regulatory authorities, actively participate in panels preparing legislation, and collaborate with national and international scientific organizations.

Project-specific regulatory team is recruited within Fraunhofer ITEM:
Scientific experts in drug development from in-house development platforms (process development and manufacturing of biopharmaceutical investigational medicinal products, non-clinical testing, and clinical trials)
Regulatory experts
Risk managers
Involvement of expertise tailor-made to the specific requirements of drug development

How we work

We provide two types of services: firstly, we support Fraunhofer ITEM’s laboratory-based and clinical contract research in the fields of manufacturing, non-clinical and clinical development; secondly, we perform services in regulatory affairs and related consulting as stand-alone services.

Either way, our services are centrally coordinated based on a project management approach, meaning that each client has a single point of contact to address daily business. The project-specific regulatory team, consisting of scientific and regulatory experts as well as risk managers, is recruited within Fraunhofer ITEM to ensure availability of expertise tailor-made to the task's specific requirements.

Contact

Contact Press / Media

Dr. Sebastian Konzok

Business Development Manager Preclinical Pharmacology and Toxicology

Phone +49 160 927 200 20