Consultancy work• Preparation of product-tailored non-clinical development strategies for drugs (small molecules, vaccines) and medical devices (biodegradable implants, topical products, drug-device combinations, substance-based devices)• Design and monitoring of non-clinical studies (pharmacology, pharmacokinetic, toxicology) and interpretation of data• Preparation of response documents to non-clinical questions from EU national authorities, EMA and US FDA• Regulatory interactions, participation at scientific advice meetings at EU national Authorities• Authoring of regulatory documents: Investigator’s Brochure, Briefing Documents, Common Technical Documents and Biocompatibility Reports for various products, including small molecules, herbal preparations, biologics and medical devices• Preparation of toxicological risk assessments and expert statementsTeaching / External trainings:• Impurity qualification• Calculation of permitted daily exposure (PDE) values in the context of shared facility production• Non-clinical drug development• Speaker at Forum Institut für Management