Germany boasts one of the world’s most advanced universal healthcare systems and a highly attractive market for pharmaceutical, medical device, and biotech manufacturers, backed by rigorous yet predictable regulatory standards.
The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) for vaccines and biologics oversee the regulatory framework in Germany, ensuring thorough scientific evaluation, national procedures, and collaboration with the EMA for centralized authorizations. Medwisdom LifeScience specializes in navigating Germany’s complex and stringent regulatory landscape. We provide specialized, end-to-end Regulatory Affairs services to facilitate smooth market entry, secure approvals, and maintain long-term compliance — making us the trusted partner for global manufacturers seeking regulatory success in this key European market.
Get Germany Compliance Support
Support for national, MRP, DCP, and centralized procedures with BfArM/PEI/EMA, including authorization applications and fast-track options.
Expert compilation, scientific review, and optimization of CTD/eCTD dossiers compliant with BfArM and EU requirements.
Full management of REACH registration, dossier submission, exposure scenarios, and compliance for chemical substances in medicinal products and devices.
Thorough quality assurance, gap analysis, technical validation, and pre-submission review to ensure error-free dossiers for BfArM/EMA.
Preparation and submission of Prior Informed Consent (PIC) notifications under the Rotterdam Convention for export of certain hazardous chemicals and pharmaceuticals.
Strategic support for stakeholder engagement, BfArM/PEI meetings, scientific advice, pricing & reimbursement navigation, and market access planning in Germany.
Comprehensive post-approval support including variations, renewals, line extensions, risk management, and ongoing compliance with German/EU regulations.
Partner with Medwisdom for specialized, reliable, and fully compliant regulatory support in Germany — from dossier preparation and BfArM approvals to lifecycle management and sustained market success.
Contact Our Germany Regulatory Experts