CDMO & CRO Consulting

We design legally sound outsourcing models for CDMOs and CROs, clarify regulatory interfaces, and minimize risks in complex supply and development structures. For reliable partnerships and efficient processes.
Dr. Barbara Klaus
Partner
Lawyer, Avvocato
Dr. Alexander Rinke
Associate Partner
Attorney at Law (Germany)
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Legal Security for Your Partnerships

Collaboration with CDMOs (Contract Development and Manufacturing Organizations) and CROs (Contract Research Organizations) is crucial for the development and manufacture of modern medicines – and at the same time complex. Contracts must not only meet regulatory requirements but also protect your economic interests. We help you implement your outsourcing strategies in a legally sound and efficient manner.

We are your trailblazer. We design and review contracts for development, manufacturing, and clinical trials, secure intellectual property rights, and regulate liability issues clearly and balancedly. We consider international standards, compliance requirements, and the specifics of your projects.

Our strength: the combination of specialized legal advice with scientific-technical understanding, business law expertise, and a global perspective.

Whether you are building a long-term partnership, awarding individual projects, or managing global supply chains – we ensure that your agreements are transparent, resilient, and future-proof.

Our goal: to minimize risks, clarify responsibilities, open up opportunities, and pave the way for maximum flexibility and sustainable growth of your innovations.
Lead the way with us. Together, we will explore new territory and successfully shape your future.

Our expertise for your field of activity


Pharmaceutical Companies

We provide support for compliance, regulatory issues, IP protection, market access, and contract drafting – as well as for product deviations, corrective actions, and communication with authorities – for legally sound processes and sustainable market success.

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Biotechnology

From R&D to approval: We support biotech companies with regulatory requirements, IP interfaces, and strategic partnerships.

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Medical Technology & Diagnostics

We support MedTech and diagnostics companies with quality and risk management, digital solutions, data compliance, and global distribution models – for safe, innovative products and sustainable growth.

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OTC & Consumer Health

We provide support for advertising law, market access, supply chain contracts, IP law, and regulatory compliance – so that your OTC and consumer health products reach consumers safely, compliantly, and successfully.

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Start-ups & Scale-ups

We support young companies with financing, IP protection, regulatory strategies, and contractual frameworks – for successful market entry.

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