My expertise includes the reimbursement and pricing of pharmaceuticals and medical devices in the stationary and outpatient service areas of the statutory health insurance (GKV). This includes practice assessment procedures before the Federal Joint Committee (G-BA) and negotiations with statutory health insurance companies and the GKV-Spitzenverband.
My regulatory consulting practice particularly encompasses placing pharmaceuticals and medical devices on the market (conformity assessment procedures, authorisation, distribution, GDP, contracts between different parts of the supply chain), wholesale authorisations, compassionate use and individual imports, clinical trials and good manufacturing practice.
I have special expertise in the field of unfair competition, particularly the laws on advertising pharmaceutical products and the co-operation between the industry, experts and patient organisations. I also regularly represent companies before the authorities and in court.
What others say…
acknowledged expert for life science companies
very experienced and good strategist