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.