CLARIFI.FI

What We Do

Clarifi helps founders turn complex regulation into clear, actionable steps.> Regulatory
• CE/MDR | FDA | EFSA Novel Foods
• Early regulatory scoping
• Pathway mapping
• Submission prep and evidence expectations
• Gap reviews
• Short-term advisory> Strategy
• Investor readiness
• Risk and evidence planning
• Due diligence support
• Grant writing support (Business Finland & EU)> Communication
• Scientific marketing
• Thought leadership & ghostwriting
• Communication training for technical teams

CLARIFI.FI

Who We Work With

Clarifi supports founders and teams building at the intersection of science, health, and technology — where innovation moves quickly, and regulation often doesn’t.MedTech & Digital Health
Regulatory support for devices, SaMD, diagnostics, AI/ML tools, and clinical technologies.FoodTech & Biotech
Novel ingredients, fermentation, precision fermentation, alternative proteins, and other emerging food-safety frameworks.Regulated Digital Innovation
Selected FinTech and RegTech projects working through AML, MiCA, and consumer-protection expectations, where clear regulatory structure is needed.Clarifi also contributes to policy and evidence work in areas such as patient safety, food innovation, and regulatory transparency.

CLARIFI.FI

About

Clarifi was founded in Helsinki by Stephen O’Rourke, a scientist and regulatory strategist with experience across MedTech, FoodTech, and emerging digital regulation. He works with founders navigating EU and US frameworks, covering devices, software, biotechnology, and novel foods.Before founding Clarifi, Stephen held Regulatory & Compliance responsibilities at Infinite Roots, where he contributed to regulatory strategy and evidence planning supporting the company’s €50M Series B funding round. He is selected as an external evaluator for the European Commission’s Health and Digital Executive Agency (HaDEA).He also works on selected policy and advocacy projects in patient safety, food innovation, and regulatory transparency, applying regulatory evidence to issues that concern the public.

Selected Media & Insights

Interviews and features on regulation, innovation, and startup strategy.Recent appearances include speaking at the Dubai International Food Safety Conference (2025).1. Startups don’t just need tech leads: They need an integrator.
Feature for EU-Startups2. Confidential by Default? The Transparency Dilemma in Europe’s Novel Foods System.
Feature for Green Queen Media3. Digital Health Meets Red Tape: What Pharma Can Learn from Software as a Medical Device
Feature for PharmaNow4. Lessons from a €50 million Series B: And why it matters at every startup funding stage
Feature for EU-Startups5. Guest article: EU novel food delays. Why bureaucracy is choking off food innovation
Feature for AgFunder NewsContact: info(at)clarifi.fi
For interviews, collaborations, or speaking invitations.

How We Work Together

Step 1: Intro call
We scope your product and identify the right pathway.Step 2: Short advisory blocks
You get clear actions, structures, and evidence expectations.Step 3: Ongoing alignment
Light-touch support as your product evolves.

Contact

Whether you’re refining a submission, mapping your regulatory pathway, or simply trying to make sense of the rules, feel free to get in touch.Clarifi offers focused conversations that turn uncertainty into clear next steps.Use the contact form below to share a few lines about your project, and I’ll get back to you within 1–2 business days.