The term life science encompasses, among other things, the pharmaceutical and medical device, food and cosmetics sectors. For these, regulations can be found, for example, in Medicines Act (AMG), im Medical Devices Act (MPG), im Food, Consumer Goods and Feed Code (LFGB) and in the cosmetics regulation. The laws and standards of the EU are also of particular importance here World Health Organization (WHO) and other international agreements.
Die Entwicklung, die Herstellung und der Vertrieb von Arzneimitteln, Medizinprodukten, Lebensmitteln und Kosmetika sind aufgrund ihrer elementaren Bedeutung für den Verbraucher und der mit solchen Produkten verbundenen Risiken vielschichtigen und komplexen
Regularien (z.B. der Guten Herstellungspraxis / Good Manufacturing Practice / GMP oder den Medizinprodukterichtlinien) unterworfen. Hieraus resultieren besondere Rechtsprobleme, die einer spezialisierten rechtlichen Begleitung und Beratung bedürfen.
The entrepreneur often starts with the question of the qualifications of the product to be sold. Everything else depends on the correct categorization, in particular the question of the requirement and type of market approval, the form of distribution and the application of certain regulatory standards.
We would be happy to make this distinction for you and accompany you on the path from the conception to the market launch of the finished products, taking into account the German and European regulations in the areas of pharmaceutical and medical device law, food law and cosmetics law.
Our expertise in the area of life science
The law firm's activities include, in particular, the creation, drafting, review and negotiation of contracts in German and English, such as: B. Confidentiality agreements, research and development contracts, contract manufacturing contracts, quality assurance agreements, distribution contracts or other sales agreements.
We would also be happy to advise and represent you in the area of medicinal product advertising law. This includes in particular advice on the development of individual advertising measures as well as out-of-court advice and legal representation in the event of warnings from competitors or against their unfair advertising measures.
In this interdisciplinary area, we have several specialized lawyers and specialist lawyers with many years of life science experience and advise and represent medium-sized pharmaceutical companies, contract manufacturers, food manufacturers and cosmetics companies nationwide and internationally.