Pharmaceutical, biotechnology and medical device companies operate in a highly regulated environment. Legal requirements affect the entire product lifecycle and increasingly interact with commercial, regulatory and strategic considerations.
We advise life sciences companies on the development and implementation of legally compliant business models, commercial activities and cooperation with business partners, healthcare providers and other participants in regulated healthcare markets.
Pharmaceutical and Medical Device Regulation
We advise on regulatory matters relating to medicinal products and medical devices and assist companies in assessing the legal requirements applicable to their products and business activities.
Our areas of advice include in particular:
- pharmaceutical and medical device regulatory matters
- regulatory requirements relating to commercialisation and distribution
- legal support for product launches and commercialisation projects
- interaction with regulatory authorities and other relevant institutions
- legal assessment of new distribution structures and business models
Promotion, Advertising and Communications
The promotion and communication of medicinal products and medical devices are subject to specific regulatory and competition law requirements. We advise companies on the legal structuring and review of their promotional and communication activities.
This includes matters relating to pharmaceutical advertising and competition law as well as the legal assessment of information and promotional activities directed at healthcare professionals, patients and the general public.
Distribution, Cooperation and Commercial Agreements
We assist companies in drafting, reviewing and negotiating agreements throughout their commercial operations. Our approach combines commercial contract law with the specific regulatory requirements applicable to the healthcare and life sciences sectors.
This includes in particular:
- distribution agreements
- supply and procurement agreements
- cooperation and service agreements
- agreements with healthcare providers and other healthcare organisations
- complex commercial and cooperation structures
Interactions with Healthcare Professionals and Organisations
Interactions between pharmaceutical or medical device companies and healthcare professionals, hospitals, medical societies, patient organisations and other participants in the healthcare sector are subject to specific legal and compliance requirements.
We advise on the legal structuring of such interactions and assist in assessing remuneration arrangements, sponsorships, consultancy agreements and other forms of cooperation.
Regulated Markets and Business Practice
Effective legal solutions must take into account not only regulatory requirements but also the actual business processes of a company. Our advice is informed by extensive experience within internationally operating pharmaceutical, biotechnology and medical device companies.
We are therefore familiar not only with the applicable legal and regulatory framework, but also with internal decision-making processes and cross-functional cooperation between Legal, Commercial Operations, Regulatory Affairs, Medical Affairs, Compliance, Quality and other business functions. This enables us to identify legal risks at an early stage while developing practical solutions for the operational needs of life sciences companies.