Healthcare & Life Sciences

Healthcare & Life Sciences – Expertise for regulated markets and innovative business models

The healthcare and life sciences sector is one of the most heavily regulated and dynamic markets in the world. Companies are confronted with complex regulatory requirements, intense competition and profound technological changes – from the development of new therapies and the digitalisation of medical devices to securing IP rights and compliance.

We provide comprehensive, interdisciplinary advice to leading international pharmaceutical and biotech companies, medical device manufacturers, hospitals, care facilities, health insurance companies and healthcare providers. Our team supports clients in their day-to-day business as well as in M&A transactions, venture capital investments and complex regulatory proceedings. We are also at your side when it comes to questions of competition and pharmaceutical advertising law, product safety and product liability, as well as in legal disputes at national and European level.

Focus on innovative solutions and digital transformation

Together with our clients, we develop legally compliant strategies for the healthcare of tomorrow – whether in the digitalisation of medical devices, cooperation projects with start-ups or the implementation of new business models. With the targeted use of modern legal tech applications, we also help to make internal processes more efficient and scalable.

An overview of our main areas of expertise

• Winding up of a research institute that was involved in clinical trials, including regulatory advice on products and materials
• Advice and representation in administrative court proceedings concerning licence and approval authorisations vis-à-vis authorities
• Telemedicine platform – from the establishment of the company and contractual structuring to the launch of the website
• Representation of a German pharmaceutical company in a Europe-wide proceeding against the EU Commission to successfully challenge a risk prevention decision
• Data protection structuring of cross-border clinical trials
• Negotiation of international supply contracts, including regulatory aspects of the import and export of medicinal products and medical devices
• Restructuring of sales organisations, particularly with regard to labour law framework conditions and works constitution co-determination
• Support for international collaborations on vaccine development and production
• Advice on regulatory requirements for mobile testing stations, digital health services and platform solutions
• Support for the market entry of innovative products, for example in the field of CBD and lifestyle health, taking regulatory requirements into account
• Legal due diligence and structuring of venture capital investments in medtech and diagnostics companies
• Advising leading associations and service providers on digitalisation strategies and cross-sector care
• Supporting pharmacies and healthcare providers in M&A projects and digital transformation processes
• Pioneering work in the field of medical cannabis

One focus of our practice is on the growing and regulatory-challenging market for medical and, increasingly, recreational cannabis. Our team is among the most experienced advisors in this segment in Europe and supports companies along the entire value chain – from market approval to operational implementation.

Under the leadership of Franziska Katterbach, Head of Healthcare & Life Sciences and one of the leading experts in the European cannabis sector, we offer you sound advice on the following topics:

• Strategies for licensing, importing, distributing and selling cannabis products in the EU
• Structuring and negotiating supply agreements and international partnerships
• Product classification, GMP/GACP compliance and advertising restrictions
• Support for clinical trials, compassionate use programmes and communication with regulatory authorities
• Legal advice on the transition from the medical to the regulated recreational market
• Establishment of effective internal compliance frameworks for vertically integrated business models
• Support with public policy, government affairs and positioning in changing regulatory environments

The healthcare and life sciences sector is developing at a rapid pace, shaped by technological innovations, increasing regulation and changing market conditions. This makes it all the more important to have legal advice that not only addresses current challenges, but also thinks ahead and takes your business prospects into account.

With our many years of experience, in-depth industry knowledge and interdisciplinary approach to consulting, we support you in acting in a legally compliant and strategically sound manner – across all phases of the product and company life cycle.

We provide clarity on complex issues, secure your scope for innovation and accompany you as a reliable partner on the path to sustainable success – both nationally and internationally.