Waterkant Legal is a virtual boutique law practice providing strategic legal counsel to Founders, Startups, Clinical Research Organizations and established Life Sciences and Healthcare Organizations.
The practice focuses on legal advisory at the intersection of Intellectual Property, Regulatory requirements and Commercial Frameworks, supporting organizations from market entry through post-approval lifecycle management.
Through comprehensive On-Demand Corporate Counsel Services, Waterkant Legal delivers tailored, senior-level legal support in a flexible, one-stop-shop model. Clients benefit from continuous access to experienced legal counsel – whether launching a new venture, expanding regulated activities or scaling operations.
Advisory services include company formation and the preparation of appropriate corporate documentation, as well as the development and implementation of robust commercial and operational frameworks designed to enable scalable and compliant growth. These frameworks cover internal governance structures, employment and contractor arrangements, and industry-standard agreements such as Material Transfer Agreements (MTAs), Master Service Agreements (MSAs), licence and collaboration agreements, Collaboration Agreements as well as other key contracts supporting R&D and operational activities.
Beyond initial setup, Waterkant Legal acts as external, on-demand corporate counsel, providing ongoing support on governance, data protection and regulatory compliance, contract negotiations and day-to-day legal operations. This ensures smooth legal workflows and continuity, particularly where internal legal resources are limited or temporarily at capacity.
With deep sector knowledge and a strong understanding of regulated markets, Waterkant Legal enables Startups, CROs and Life Sciences and Healthcare Organizations to focus on innovation, growth and the successful translation of science into medicines and medical devices – supported by reliable, pragmatic and business-oriented legal counsel at every stage.
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Services
Comprehensive Legal Support
Intellectual Property Strategy
Waterkant Legal advises Life Sciences and Healthcare Organizations on Intellectual Property questions that arise in regulated environments, where IP decisions are closely linked to regulatory pathways and commercial objectives.
The focus lies on shaping IP strategies that support product development, collaboration structures and long-term value creation. Legal advice is designed to anticipate regulatory and commercial implications early on, helping organisations make informed decisions and avoid friction at later stages.
Rather than treating IP in isolation, Waterkant Legal approaches intellectual property as an integral part of the overall product and business strategy, particularly for pharmaceutical and medical device products.
Regulatory & Commercial Framework Services
Waterkant Legal supports organizations in building coherent Regulatory and Commercial Frameworks that provide a stable legal foundation for R&D, market entry and post-approval operations.
These frameworks are designed to reflect the realities of regulated products and recurring operational activities. For early-stage ventures, this includes establishing the legal structures required to operate and grow in a compliant manner. For more mature organisations, the focus shifts to scalable frameworks that support collaboration, manufacturing, distribution and other key operational relationships.
By developing lean, reusable frameworks aligned with regulatory requirements and commercial workflows, organisations are enabled to manage risk, ensure consistency and scale their activities efficiently.
On-Demand Corporate Counsel Services
In addition to framework-based advisory work, Waterkant Legal provides On-Demand Corporate Counsel Services for Life Science & Healthcare Organizations that require ongoing, flexible legal support or additional expertise and temporary in-house capacity.
Acting as an external extension of internal legal and compliance functions, Waterkant Legal supports day-to-day legal operations, governance-related matters, negotiating commercial and research-related agreements and the legal assessment of operational and strategic initiatives as they arise. This model is particularly suited for organisations experiencing growth, increasing regulatory complexity or temporary capacity constraints.
On-Demand Corporate Counsel Services ensure continuity, informed decision-making and pragmatic legal guidance – delivered precisely when needed and closely aligned with the organisation’s business and regulatory objectives.
Why Waterkant Legal?
- Life Sciences & Healthcare Focus
Waterkant Legal is dedicated to advising Life Sciences and Healthcare Organizations, with a particular focus on biotech, pharmaceutical and medical technology companies. Drawing on many years of hands-on experience working closely with regulated businesses, Waterkant Legal understands the specific legal, regulatory and operational challenges these organisations face throughout the product lifecycle.
- Integrated Legal Counsel across IP, Regulation & Commercial Matters
Rather than addressing legal issues in isolation, Waterkant Legal provides integrated advice across Intellectual Property, Regulatory requirements and Commercial Frameworks. This holistic approach allows clients to make informed decisions, reduce regulatory and contractual risk and build sustainable structures for growth.
- On-Demand Corporate Counsel Model
Waterkant Legal acts as an external, on-demand legal counsel, offering senior-level support that integrates seamlessly with internal teams. This model provides continuity and strategic oversight across legal and regulatory matters, without the need to coordinate multiple advisors or expand permanent in-house resources.
- Efficient, Pragmatic and Transparent Advisory
As a virtual boutique law practice, Waterkant Legal delivers focused, efficient and transparent legal advice. The emphasis lies on practical, business-oriented solutions that are tailored to regulated environments – without unnecessary complexity, bureaucracy or overhead.
Competent. Transparent. Fair.
Dr. Nikolaus Rafael Marek
Attorney at Law admitted to German Bar & In-house Counsel (Syndikusrechtsanwalt)
I’m Nikolaus, founder of Waterkant Legal and a strategic legal counsel specialising in life sciences and healthcare.
Alongside my advisory work at Waterkant Legal, I serve as Senior Legal Counsel at a biotech company active in pharmaceutical research and development. I combine several years of in-house experience with prior work at an international law firm in the life sciences and healthcare sector.
My practice focuses on advising companies on Intellectual Property, Regulatory and Commercial Frameworks in regulated environments. I support organisations across the full lifecycle of pharmaceutical and medical device products – from early-stage structuring and market entry to post-approval operations and scale-up.
Having worked closely with internal teams, management and external stakeholders, I bring a strong in-house perspective to my advisory work. This enables me to deliver legal solutions that are not only legally sound, but also operationally feasible and aligned with commercial and strategic objectives.
Over the years, I have been involved in numerous complex, cross-functional projects, supporting clients not only on legal questions, but also as a strategic sparring partner on structurally and commercially relevant issues at the interface of law, regulation and business.
I am admitted to practise as an attorney-at-law in Hamburg and work primarily in German and English, with additional working proficiency in Polish.
“It’s not the big that eat the small, but the fast that eat the slow.”
Eberhard von Kuenheim
Chairman of the Board of Management, BMW AG (1970 – 1993)
Client Success Stories
Helping Biotech Startups Thrive
“Dr. Marek’s insights and guidance were instrumental in navigating the complexities of our startup’s formation and initial funding rounds. His understanding of both the legal and commercial aspects of the biotech industry gave us confidence on our journey forward.” – Client Testimonial
Trusted Legal Partner for Startups
“Working with Waterkant Legal has been a game-changer for our startup. From incorporation to navigating complex agreements, the legal guidance has been clear, strategic, and always tailored to our needs. Having a trusted legal partner who truly understands the challenges of startups – especially in biotech – gives us the peace of mind to focus on growth. Highly recommended!” – Client Testimonial
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