Regulatory Strategy CROs in Germany

Frankfurt-based specialty CRO focusing on endocrinology and oncology clinical development with strong European regulatory expertise.

Hamburg-based dermatology specialty CRO established in 1992, providing regulatory consulting and Phase I-IV clinical trial management for pharmaceutical, device, and cosmetic dermatology products.

Munich-based specialty CRO focused on medical device and in vitro diagnostic clinical studies, providing regulatory consulting, study monitoring, and clinical evaluation reports across Europe.

German regulatory affairs consultancy providing EU regulatory strategy, marketing authorisation applications, and scientific advice for pharmaceutical and biotech sponsors.

Munich-based mid-size CRO providing Phase I-IV clinical trial management, regulatory consulting, pharmacovigilance, and medical affairs across Europe and Asia.

Global CRO with nearly 1,000 employees covering 30+ countries, providing full-spectrum multilingual clinical development from early phase through post-approval in oncology and CNS.

Specialist CDMO for cell and gene therapy products offering GMP clinical and commercial manufacturing and development solutions for ATMPs from German, US, and Japanese facilities.

Eastern and Central European CRO founded in 2005, providing Phase I-IV and bioequivalence services in oncology and infectious disease across 20+ countries.

European full-service CRO formed by the 2024 merger of palleos healthcare and OCT Clinical, covering Western and Eastern Europe across 29 therapeutic areas from Wiesbaden, Germany.

Global regulatory affairs and drug development consulting firm providing IND/NDA/MAA filing support, clinical development strategy, and pharmacovigilance services.

European regulatory affairs and pharmacovigilance services provider offering end-to-end regulatory strategy, submission management, and post-authorization compliance for pharma and biotech companies.

Swiss/German full-service CRO providing Phase I-IV clinical trial management, regulatory consulting, and medical writing with offices across Germany, Austria, and Switzerland.

Medical writing and regulatory consulting CRO providing clinical study reports, investigator brochures, CTD modules, and submission documents for FDA and EMA regulatory filings.