R&D Compliance
Navigate complex regulation without slowing down innovation. Contact us for expert support in R&D, where regulation is strict and the stakes are high.
Current Reality
Inaction creates risk
Non-compliance can mean material fines (30+ million euros), market restrictions and serious reputational damage. Moreover, it often prevents market access to EU markets, regulatory approvals or subject recruitment.
Extensive and changing regulation
Research and development (R&D) activities are subject to extensive and complex regulation. The regulation is also changing significantly in 2026, due to EU-level changes to data use and AI regulations.
Trust as Foundation
R&D activities fundamentally depend on trust of the research participants, partners and investors. A single compliance failure can undermine relationships, freeze funding and limit future research opportunities.
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Make innovation compliant, not complicated.
How we help
Any organization can meet regulatory requirements effectively with the right guidance, documentation and practical governance structures. We help you achieve compliance efficiently without disrupting your operations.
Training
We deliver practical training for boards and staff. Examples include:
tailored training (e.g. data protection in research)
board briefings on recent and upcoming regulatory changes
role-specific guidance for research, technology and administrative teams.
R&D Compliance Support
We support regulatory compliance end to end. Examples include:
guidance on international transfers or secondary use of data
research agreements (clinical trial agreements, consortium agreements, MTAs and more)
playbooks and guides (e.g. contract playbooks)
Tailored Support
We offer tailored support for complex or high-stakes environments. Examples include:
guidance on AI use in R&D
assitance in preparting responses to regulatory authorities
assessing applicable legislation in a novel, complex project.
Why Regulyn?
We communicate clearly.
The regulation is complex enough. We explain the legal requirements without regulatory jargon or unnecessary complexity. We ensure you stay updated thoughout the engagement.
We make compliance work in practice.
We have spent over a decade working in regulated environments and understand how compliance efforts succeed or fail in real organizations. We turn legal requirements into actionable teams can actually implement.
We care about making you successful.
Our work is not done when we deliver documents. Our job is done when your team understands the requirements and you can demonstrate compliance with confidence. That is what we optimize for.
Sector experience that makes a difference
We work across industries, but we bring deep knowledge in sectors where regulation is particularly complex. This sector knowledge means we understand your context from day one.
Research & Academia
We understand the unique challenges of environments where innovation must coexist with compliance. We know what matters in your environment.
Healthcare & Life Sciences
We understand how requirements layer onto clinical trials, patient care and medical devices. We know the regulatory intersections and how to navigate them efficiently.
Technology
We understand the varying needs of technology companies from startups to established corportations. We calibrate our approach to where you are.
Navigate R&D Regulation with Confidence
Broad and Complex Landscape. R&D operates in one of the most heavily regulated environments: clinical trials regulations, GDPR, ethics frameworks, medical device rules, AI Act requirements, and sector-specific legislation all apply. These are legal obligations with administrative fines, project suspensions, and reputational consequences for violations.
Upcoming changes. The R&D regulation field is changing in 2026 with new and updated regulations proposed the EU (AI Act, pharma package, EHDS and more). You can explore resources from the Knowledge Center.
We turn that complexity into clarity. We assess your projects, design practical governance structures, and offer actionable advice and practical compliance programs that work in the real world.
What you Achieve
Trust and Control
Demonstratable compliance strengthens customer and investor trust. It also reduces exposure to fines, reputational harm and operational disruption.
Momentum
Compliance enables access to regulated markets. Clear rules, defined processes, and assigned responsibilities speed up decisions and reduce friction.
Readiness
Regulation will keep evolving, and strong governance helps you adapt without constant and costly rework. Building the foundation early delivers long-term value.
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Client Testimonials
Our Consulting Process
Assessment
We start by understanding your unique position, goals and challenges. Together, we define the next steps.
Implementation
We analyse the regulation, train your staff or plan governance models, depending on the project. Whenever possible, we work in close collaboration with you.
Handover
We ensure that you understand the deliverables and can use them in real life. We provide a written summary or review the results in a meeting.
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Frequently Asked Questions (FAQ)
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Compliance covers the ethical and regulatory obligations that apply to R&D projects. This includes, for example, data protection (e.g. GDPR), regulation governing clinical research (such as the CTR and MDR), and adherence to ethical standards.
Research agreements are a key practical tool for ensuring regulatory compliance. In some cases, a written agreement is mandatory under applicable legislation or funding conditions.
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The General Data Protection Regulation (GDPR) provides certain flexibilities for processing personal data in scientific research, often referred to as the research exemption.
In practice, this allows existing data to be reused for scientific research without necessarily obtaining new consent, as scientific research is considered compatible with the original purpose of collection. In specific circumstances, certain data subject rights (such as the right to erasure) may also be restricted for research purposes.
However, these exemptions can only be relied upon when:
appropriate safeguards are implemented, such as pseudonymisation; and
the activity qualifies as genuine scientific research (based on a research plan and not merely market research).
National legislation may also impose additional requirements on the processing of personal data in research.
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The EU Artificial Intelligence Act includes a specific research exemption. The AI Act does not apply to AI systems or models (or their outputs) that are developed and used solely for the purposes of scientific research and development.
This exemption may apply, for example, to academic prototype development or the training of a model intended solely for research use. However, the exemption no longer applies once an AI system is placed on the market or when it is no longer used exclusively for research or development purposes. Real-world testing is also subject to additional requirements.
The AI Act further supports innovation through mechanisms such as national regulatory sandboxes.
Importantly, even when the AI Act does not apply, other legislation continues to apply. For example, data protection requirements and clinical research safety obligations must still be observed.
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In research projects, it is essential to document key terms in a written agreement. Core areas to address include the project implementation, data protection, confidentiality, intellectual property rights and liability.
The appropriate agreement depends on the scope of the collaboration, the parties involved and the applicable legislation. Some funders also require the use of their own contract templates.
Common types of research agreements include:
Non-Disclosure Agreement (NDA): used before initiating collaboration, unless confidentiality is covered elsewhere
Consortium Agreement: particularly common in academic and EU-funded collaborative research
Material Transfer Agreement (MTA): required when biological materials or other samples are transferred between parties
Clinical Trial Agreement (CTA): required for clinical drug or medical device studies
Data Transfer Agreement (DTA): used when datasets are transferred as part of the collaboration
Contact us
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