Life Sciences

Life Sciences in the regulated market: what companies need now 

The Life Sciences sector is one of the most heavily regulated markets in the world. Complex requirements not only determine market access, but also time-to-market, liability risks and the scalability of your business models. 

We offer you reliable legal guidelines along the entire value chain. Our aim is to implement requirements with legal certainty, manage liability and increase your investment and cooperation capabilities long term. 

Regulatory issues & approval/licensing (medicinal products, biologics, medical devices) 

We support companies with regulatory classification, strategy and implementation – from the idea to marketing. The focus is on a reliable basis for decision-making and well-documented processes that meet the requirements of audits, inspections and authorities. 

Typical topics of regulatory advice 

• Regulatory product classification and approval/compliance strategy 
• Requirements for quality, safety and performance certificates 
• Governance and compliance structures for regulated organisations and supply chains 

Clinical studies & research 

Clinical trials are a core risk area, both legally and operationally. We provide advice on legal structuring and safeguarding – particularly where study design, data flows and responsibilities overlap. 

Components 

• Drafting and negotiating contracts (trial centres, CROs, service providers, sponsor structures) 
• Legal advice on administrative and ethics processes 
• Liability and insurance issues, responsibility and delegation models 

Approval/licensing and market access in the Life Sciences sector: national and EU procedures 

For both national procedures and EU procedures: market access is often a strategic project with legal "go/no-go" decisions. We support you in structuring approval and licensing procedures, risk analysis and implementing the associated compliance obligations. 

The law on advertising in the field of health and distribution in the Life Sciences sector: advertising, distribution channels and market surveillance 

Regulatory requirements do not end with approval. Advertising, distribution and market surveillance are frequent triggers for regulatory, competition or liability risks – especially with digital distribution models and data-based product offerings. 

Key points 

• Legally compliant marketing and communication concepts (including digital channels) 
• Contract and compliance checks for sales, distributors and platform models 
• Support for market surveillance, complaints and recalls/corrective measures 

Product liability and risk management for medicinal products, medical devices and health AI 

Liability risks often arise at interfaces: Product changes, software updates, data dependencies, external components or unclear responsibilities in the supply chain. We support you in setting up a robust risk management system – legally, contractually and procedurally. 

Typical services 

• Liability analysis, risk and crisis management (including recall/safety measures) 
• Contractual clauses on liability, indemnification, quality and audit rights 
• Interface between regulatory issues, quality system and incident response 

IP and protecting expertise in the Life Sciences: Patents, IP strategy and defence 

Property rights are of central importance for value creation, financing and cooperation. We advise you on protecting and defending your intellectual property rights, especially in scenarios with several partners, development stages and international aspects. 

Focus areas 

• IP strategy for product development and platform technologies 
• Protecting expertise, employee inventions, licensing and enforcement 
• IP-relevant contract drafting in cooperations and transactions 

Data protection in Life Sciences and Digital Health: GDPR, patient data and data strategy 

Data is a key success factor in research, real-world evidence and digital health solutions – and at the same time a highly sensitive risk and regulatory issue. We provide support with legally compliant data flows, role concepts, responsibility models and sustainable data strategies. 

Components 

• Data protection concepts for clinical research and study operations 
• Contract and governance models for data usage (including service provider management) 
• Data protection and compliance for digital health and AI applications 

Regulating AI in the area of Life Sciences: Governance, risk classification and contracts 

AI-based systems in the Healthcare sector entail specific obligations in terms of governance, risk classification, documentation and contract design. We advise on regulatory requirements, internal control structures and the legally compliant integration of AI into product and business models. 

Typical components 

• Governance and accountability models for AI in the company 
• Risk assessment and documentation requirements 
• Contractual protection in development, operation and procurement (including provisions on data and liability) 

Contracts and cooperations in Life Sciences: Licensing, joint ventures and business development 

Innovations in the field of Life Sciences are often the result of collaborations between pharmaceutical, biotech and medtech companies, research institutions, start-ups and investors. We draft and negotiate contracts in such a way that IP, data, milestones, quality obligations and exit scenarios are regulated consistently. 

Key points 

• Cooperations, licensing and development agreements 
• Joint ventures, strategic partnerships, commercial agreements 
• Transaction-related advice for growth, investments and structuring 

Competition law and pharmaceutical antitrust law for cooperations and distribution models 

Cooperation and distribution models can trigger antitrust and competition law risks – for example in the case of data cooperation, platform models, exclusivity or joint marketing strategies. We check, structure and support these projects with legal certainty. 

ESG and compliance in Life Sciences: supply chain, governance and reporting obligations 

Regulatory issues, supply chain issues and governance requirements are becoming increasingly intertwined. We advise on compliance structures, supply chain requirements, environmental and governance obligations as well as internal guidelines and control mechanisms.