Pharma Laws
Pharma laws is an interdisciplinary field of law governing the rules for medicinal products, medical devices and medical aids.
More about pharmaceutical law
Pharma laws cover areas such as:
Drug research and development (clinical trials (e.g. GCP) | drug manufacturing (e.g. GMP) | regulatory approval of medicines incl. orphan drugs, narcotics, and special therapeutic fields such as homeopathy | patent law, data exclusivity, industrial property rights | contract law (e.g. co-development, co-promotion, license agreements, contract research, contract manufacturing) | medical devices (classification, conformity assessment procedures, CE marking) | food supplements, functional food, health claims | market entry / market access (pricing legislation, reimbursement, Health Technology Assessment (HTA) | marketing and sales incl. parallel-/reimport, competition law, drug advertising law | safety and governance (quality assurance, compliance systems, anti-counterfeit protection, data protection and privacy, drug safety, medical devises safety) | liability and sanctions (drug liability, medical devices liability, criminal law relating to medicines and medical devices)
- Distinction issues (drugs, medical devices, cosmetics)
- Contract design (pharmacovigilance, clinical trials)
- Creation / Maintenance of Pharmacovigilance Contracts (PV Agreements / SDEAs)
- Medical devices (conformity assessment procedure, vigilance)
- Support of Mergers & Acquisitions
- General Data Protection Regulation (GDPR), in particular in pharmacovigilance
- Drug advertising law / Information Officer
NEW: Dr. Monika Boos is TUEV-certified AI Compliance Officer. Consequently, she is a qualified point of contact for the legally compliant implementation for the requirements laid down in the European AI Act (Regulation (EU) 2024/1679).
"AI Compliance Representatives (TÜV)" have in-depth knowledge of the EU AI Act. They are familiar with the risk classification of AI and are able to support companies in fulfilling compliance requirements in accordance with the EU AI Act.
TUEV Rheinland Academy GmbH
The certificate from TUEV can be provided upon request.
» If you think compliance is expensive, try non-compliance. «
Paul McNulty, former U.S. Deputy Attorney General
The initial consultation is of course free of charge.