Healthcare & Life Sciences

Legal consulting in the area of pharmaceutical/healthcare & life sciences law has been one of the pillars of our law practice for many years. Based on our extensive experience representing well-known companies in the pharmaceutical, medical products, genetic and bio-engineering industry, we have special insight in these matters and quickly familiarize ourselves with complex medical, biological and chemical nature.

Even at the pre-approval stage we provide you with comprehensive consulting on legal matters related to research and development including clinical studies • Contract drafting and negotiating with CROs, trial centers, clinical investigators, laboratories, etc.
• Confidentiality agreements
• License agreements while ensuring all your pre-marketing • Legal services in the development of pre-marketing strategies
• Consulting services in advertising law for pre-marketing of pharmaceuticals
• Consulting for pharmaceutical companies on statutory disclosure requirements regarding pharmaceuticals in the approval process
• Consulting on product labeling/information activities are legally sound. We also draft and negotiate clear and precise agreements in the areas of contract manufacturing and quality assurance • Contract manufacturing agreements
• Development and implementation of quality management systems
• Consulting on production and quality requirements for pharmaceuticals and medical products (GMP, GCP, validation, auditing, etc.) . When it comes to consulting on marketing and sales strategies • Review of marketing campaigns and claims for pharmaceuticals, medical products, food supplements, foods, genetic and bio-engineering products
• Co-marketing issues
• Labeling duties, distribution requirements and liability aspects, specifically relating to pharmaceutical and medical products law as well as drafting and negotiating international license and distribution agreements • Consulting on licensing structures, license agreements and licensing strategies
• National and cross-border commercial & distribution agreements
• International requirements for the import, export and distribution of pharmaceuticals, medical products and bio-engineering products
• Adaptation of international marketing & sales strategies to German laws , you benefit further from our in-depth legal and technical expertise. We are also familiar with all the legal facets of pricing and procurement procedures • Legal advice on pricing according to drug price regulations
• Legal advice on give-aways, discounts, bonuses, bundle/combination offers and other promotional measures including tender and discount agreements in the industry.

In the area of compliance • Consulting on sponsoring & marketing requirements under competition, professional, social and criminal law
• Cooperation between pharmaceutical companies and health professionals (observational studies, joint development, etc.)
• Consulting on the codes of the pharmaceutical/medical products industries (VFA, AKG, etc.)
• Development & implementation of compliance systems
• Compliance workshops , we review your sales structures, develop legally solid concepts and train your staff accordingly. Our specialexpertise in medical advertising laws and our extensive experience in handling competitor disputes • Preparation/review of warning letters
• Legal representation in temporary injunction and litigation proceedings
• Legal review of marketing material pharmaceuticals and medical products
• Legal advice on the parallel/re-import of pharmaceuticals are highly sought after by companies in the industry and is also continuously substantiated by our top rankings in Germany’s law firm guides JUVE and Legal 500.

Your Partners:
Dr. Holger Alt
Dr. Claudia Böhm
Dr. Anselm Brandi-Dohrn