Specialized legal counsel for AI, R&D and agreements
Regulatory Expertise for High-Stakes Decisions. Trusted by organizations navigating complex EU regulations.
✓ €80M+ contract portfolios managed
✓ Serving clients with €1B+ operational budgets
✓ 10 + years leading institutional compliance programs
Enabling responsible operations
Regulyn provides expert guidance to organizations navigating EU regulatory requirements - delivering clarity, precision, and practical solutions teams can implement.
Regulatory compliance is unavoidable. Regulatory confusion is not.
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Regulyn specializes in three interconnected domains: AI compliance, R&D regulation and agreements.
This focused practice ensures depth of expertise where it matters most.
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Regulyn supports organizations across the life sciences, technology, and academic sectors.
Regulyn works with organizations that need more than general legal advice - those facing high-stakes decisions where regulatory uncertainty, technical complexity, and commercial objectives intersect.
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Regulyn serves clients in Finland, across the European Union, and global organizations entering EU markets or navigating European regulatory frameworks.
Recent Insights
Services
Regulyn’s practice focuses on areas where regulatory compliance intersects with innovation.
AI Compliance
Deploy, develop, and import AI systems with regulatory certainty. Regulyn turns AI Act requirements into clear compliance roadmaps and governance structures.
Typical engagements:
AI Act risk classification and compliance guidance
AI Governance framework development
AI Act and sector regulation alignment
AI regulation training for leadership
Learn more >
R&D Compliance
Initiate R&D projects in compliance with EU regulatory requirements. Regulyn advises on clinical trials, medical research, data use and AI in research contexts.
Typical engagements:
Clinical research compliance and regulatory strategy
Data use and sharing guidance (GDPR, EHDS, international guidelines)
AI-enhanced research and regulatory requirements
Research regulation training for research teams
Agreements
Protect your interests with legally binding agreements . Regulyn drafts, negotiates and reviews agreements essential for research, technology and commercial activities.
Typical engagements:
Research Collaboration Agreements (drafting or negotiation of IP rights, publication, liability)
Clinical Trial Agreements
Service Agreements (AI systems, research services, CRO engagement)
Tailored template development (clause libraries, NDA/CTA/MTA templates)
Why Regulyn
Organizations choose Regulyn the combination of specialized legal expertise, sector knowledge, and clear insight .
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Regulyn focuses exclusively on AI regulation, R&D compliance, and related agreements.
Every engagement receives direct involvement from experienced counsel. This ensures strategic insight, efficient decision-making, and clear guidance throughout.
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Regulyn has deep understanding of environments where regulatory compliance intersects with innovation.
With over a decade working in healthcare, life sciences, and research institutions, Regulyn understands the operational realities of implementing compliance in complex organizational context.
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Regulyn’s clear communication and strategic insights ensure clients understand their regulatory requirements and can proceed with confidence.
Client Testimonials
How Engagements Work
Every custom engagement follows a structured three-phase approach designed to deliver clear results while maintaining transparency.
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20 minutes | Complimentary | By appointment only
Regulyn assesses the regulatory situation, maps applicable requirements, and recommends next steps with defined scope and timeline. No obligation to proceed.
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Defined scope | Collaborative approach
The agreed work is delivered: agreement negotiation, regulatory analysis with clear recommendations, governance frameworks, or other scope-defined deliverables.
Clients are kept informed with regular updates throughout the engagement.
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Structured review meeting | Clear overview
Results are reviewed in detail with implementation guidance. Clients receive clear overview of the engagement and next steps to proceed independently with confidence.
Leadership
Katri Harjuveteläinen
LL.M, Doctoral Candidate, CIPP/E, CIPM, FIP
Founder, Chief Legal Advisor
Katri Harjuveteläinen leads Regulyn's practice with over a decade of experience in research regulation, data protection, and AI compliance.
Organizations engage Regulyn for the combination of specialized legal expertise, sectoral knowledge and clear advice.
Clients receive senior-level counsel throughout engagements. Delivery is lead by Katri, supported with a curated network of senior experts as required
Next steps
Regulyn works with organizations facing regulatory complexity where specialized expertise creates clear value.
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If you are:
navigating AI Act compliance requirements
planning or conducting clinical research
planning data use for R&D
negotiating high-value agreements with complex IP or data rights, or
facing other regulatory challenges at the intersection of innovation and compliance.
Regulyn can help you understand your requirements and plan the next steps for full compliance.