About

Regulyn is a Nordic legal advisory firm providing organisations with expert support in AI Act compliance, research regulation, and complex agreements.

Trusted by organizations navigating complex EU regulations

✓ €80M+ contract portfolios managed

✓ Serving clients with €1B+ operational budgets

✓ 10 + years leading institutional compliance programs

Regulyn provides specialized legal counsel at the intersection of AI regulation, research compliance, and agreements.

We work with organizations navigating EU's most complex regulatory frameworks - where the AI Act meets medical device regulation, where clinical trials involve novel data use, where research collaborations require sophisticated IP and data rights allocation.

Our practice is intentionally focused rather than broad. We do not attempt to serve every legal need—we concentrate on regulatory domains where we have deep, demonstrated expertise developed through years of institutional implementation experience. This specialization ensures that when you engage Regulyn, you're working with counsel who has navigated your exact regulatory challenges, not generalists learning your domain on your engagement budget.

What Regulyn does

How Regulyn is different

  • Regulyn's founder, Katri Harjuveteläinen, did not build regulatory expertise through advisory work alone. Before founding Regulyn, she led institutional data protection and AI compliance programs for healthcare and research organizations.

    This meant building governance structures, developing policies and procedures, training organizational staff, responding to regulatory inquiries, managing data breaches and incidents, and navigating the operational reality of implementing compliance in complex institutional environments.

    This background shapes our work fundamentally. We do not develop compliance solutions that look impressive to regulators but fail in practice. We create frameworks that address regulatory requirements while fitting organizational operational reality.

  • Regulyn's engagement model ensures you work directly with experienced counsel, not a team of junior associates supervised from a distance.

    You receive the expertise you are paying for - guidance from senior expert with demonstrated experience.

    For organizations with high-stakes regulatory challenges and demanding timelines, this model provides what they actually need: experienced counsel who can assess their situation efficiently, identify critical issues quickly, and provide guidance that directly addresses their requirements.

  • Regulyn's assessment-first approach ensures organizations make informed decisions about external legal counsel.

    We do not assume every inquiry requires comprehensive engagement. Some situations are straightforward enough that organizations can address them with internal resources or with a fixed-scope engagement. Others involve regulatory questions where specialized counsel creates clear value.

    Our goal is helping you understand which category describes your situation.

    This transparency sometimes means declining potential engagements. We are comfortable with that outcome because our goal is providing genuine value to organizations with legitimate regulatory needs, not maximizing billable hours by selling services organizations do not need.

Who Regulyn serves

Regulyn works with organizations at different stages and across different sectors. The common thread across these organizations is regulatory complexity that justifies specialized legal expertise.

✓ Life Sciences or Pharmaceutical Companies

✓ Healthcare Providers

✓ Research Institutions and Universities

✓ Technology Companies (AI, Healthtech)

✓ Organizations using AI in their operations

Geographic Scope

  • Regulyn is based in Finland, providing us with deep understanding of Nordic regulatory environments and practical knowledge of working with Finnish regulatory authorities.

    However, our expertise extends across the European Union - we advise on EU-level frameworks like the AI Act, Clinical Trials Regulation, and GDPR that apply across member states.

  • We also work with non-EU organizations entering European markets or navigating European regulatory requirements.

    If you are US-based healthcare technology company deploying AI systems in the EU, a Swiss pharmaceutical company conducting clinical trials across EU countries, or an organization from any jurisdiction facing EU regulatory requirements, we can help you understand and address those obligations.

  • Our Nordic base provides advantages for organizations operating in this region - we understand local regulatory authority practices, institutional cultures, and practical implementation considerations that shape regulatory outcomes.

    Our EU-level expertise makes us valuable to organizations regardless of their primary jurisdiction, as long as they face European regulatory complexity.

Leadership

Katri Harjuveteläinen

LL.M, Doctoral Candicate

Founder, Chief Legal Advisor

Katri Harjuveteläinen leads Regulyn's practice with over a decade of experience in research regulation, data protection, and AI compliance.

Background:

  • Led institutional data protection and AI compliance programs for healthcare and research organizations

  • Managed complex contract portfolios exceeding €80M

  • Led international, high-stake contract negotiations and R&D initiatives contracting

  • Certified Privacy Professional (CIPP/E, CIPM, FIP)

Organizations engage Regulyn for the combination of specialized legal expertise, sectoral knowledge, and implementation focus.

Clients receive senior-level counsel throughout engagements. Delivery is lead by Katri, supported with a curated network of senior experts as required

Katri Harjuveteläinen, Founder of Regulyn, expert in AI compliance (AI Act, AI Act Readiness, AI lawyer), data protection (GDPR, NIS2) and research law (clinical trials, secondary data use, medical research).

Our values

Integrity

We provide high-quality legal advisory services that enable responsible operations. Ethical conduct is non-negotiable.

Responsibility

We are committed to promoting responsible practices in research, innovation and organisational operations. We reflect this commitment in how we work, prioritising digital, sustainable ways of delivering our services.

Collaboration

We believe that the best results are achieved through collaboration and clear communication. We work as a trusted partner to our clients.

Next steps

If you are facing regulatory complexity in AI compliance, clinical research or technology agreements, our assessment process provides clarity about your requirements and appropriate next steps.

This assessment is complimentary and carries no obligation.