Regulatory research and risk assessment in drug development

© Photo Fraunhofer ITEM

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.

Regulatory research and risk assessment of chemical substances

Track record

Fraunhofer ITEM’s regulatory staff accompanied the development of small molecules, biopharmaceuticals, and ATMPs from bench to clinical phase II, provided the regulatory development strategy, organized and performed scientific advice meetings with the competent authorities, and filed applications for clinical trial authorizations including preparation of the IMP dossier and core documents.

Our clients represent the entire pharmaceutical sector, including not only academia, biotechs and big pharma, but also authorities, funding bodies, and public-private partnerships.

How we work

© Photo Fraunhofer ITEM

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.

Our team of specialists covers the whole pharmaceutical development chain and offers:

Preparation of a regulatory strategy to take products from lab to market:
Project planning focusing on regulatory compliance, Integration and cross-linking of different R&D disciplines (e.g. what quality/quantity does a product need to have when and for which study?), Regulatory troubleshooting and addressing of regulators‘ concerns (experimental strategy, independent experts’ statements, summaries)

Interaction with regulatory authorities:
Scientific and regulatory advice meetings with authorities (national competent authorities, EMA, FDA (US representative available)), ATMP classification and certification with EMA, application for orphan drug designation with EMA and FDA, EMA PRIoritiy MEdicines (PRIME) scheme application after proof of concept, application for authorization of clinical trials with national authorities and ethics committee

Preparation of regulatory documentation:
Study reports in formats acceptable to the regulatory authorities (e.g. tabulated summaries), support in dossier preparation, e.g. IMPD and CTD, core documents according to ICH E6, e.g. IB and CTP

Risk assessment:
Risk-based approach in development, including ATMPs, e.g. according to Directive 2001/83/EC, classification regarding maximum residue limits according to Regulation (EU) No. 37/2010, impact assessment and preparation for new procedures (e.g. Regulation (EU) No. 536/2014, ICH E6R2), environmental risk assessment for GMOs according to Directive 2001/18/EC, environmental risk assessment according to EMEA/CHMP/SWP/4447/00 (strategic planning, risk assessment, study performance and monitoring, revision)

Regulatory research:
Development of new tools, standards, and approaches for assessment of regulated products (safety, efficacy, quality, performance), critical path research along the development process (safety assessment, evaluation of medical utility, product industrialization)

Your benefit

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