The term life science includes, among other things, the pharmaceutical and medical devices industries, the foodstuffs industry, and the cosmetics industry. There are regulations for these, for example, in the German Pharmaceutical Act (AMG), the German Medical Devices Act (MPG), the German Foods, Consumer Goods and Feedstuffs Code (LFGB) and the Cosmetics Directive. The laws and standards of the EU, the World Health Organization (WHO), and other international conventions are also particularly important in this respect.
The development, production, and sale of pharmaceuticals, medical devices, foodstuffs, and cosmetics are subject to multi-layered and complex regulations (e.g. Good Manufacturing Practice (GMP), or the medical device guidelines) due to their primary importance for consumers and the risks associated with such products. This creates special legal issues, which require specialized legal support and advice.
In the beginning, companies are often faced with the issue of product qualification. Everything else depends on the correct categorization, particularly the question as to the requirements and type of market authorization, the type of distribution, and the application of certain regulatory standards.
We will be pleased to assume this task and support you in the implementation of your projects, from the concept phase to the launch of the finished products, while adhering to German and European guidelines in the areas of pharmaceutical and medical device law, foodstuff law, and cosmetics law.
Our expertise in the life science industry
The main activities of our company include the preparation, design, review, and negotiation of contracts, in German and English, such as confidentiality, research and development, contract manufacturing, quality assurance, distribution, and other sales agreements.
We will also be pleased to advise and represent you with respect to the German Law on the Advertising of Medicinal Products (Heilmittelwerberecht). This includes, in particular, consultations during the development of individual marketing measures as well as out-of-court consulting and representation before the court in the event of official warnings from competitors or in claims against their unfair marketing measures.
We have several specialized lawyers with many years of life science experience in this interdisciplinary area and advise and represent German and international medium-sized pharmaceutical companies, contract manufacturers, foodstuff manufacturers, and cosmetic companies.