clarifi.fi
Regulatory Clarity for Startup Founders
Compliance doesn’t need to be a mystery. Clarifi helps founders navigate CE, FDA, and Novel Food requirements — without jargon, overwhelm, or €50k retainers.
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Who We Help
Clarifi supports founders and teams building at the edge of science, health, and technology — where innovation moves fast, but regulation often doesn’t.> MEDTECH & DIGITAL HEALTH
We help medical device and software innovators make sense of CE, FDA, and MDR requirements early, so regulatory clarity becomes a competitive advantage — not an afterthought.> FOODTECH & BIOTECH
We guide founders working with novel ingredients, fermentation, or alternative proteins through the EU and US safety frameworks, turning uncertainty into structured progress.> FINTECH & REGTECH
We support digital finance and blockchain teams navigating evolving AML, MiCA, and consumer-protection rules — translating regulation into clear product actions.Whatever you’re building, Clarifi helps you connect innovation with compliance — clearly, practically, and on your terms.
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The Problem
The old way doesn’t work for startups.Founders spend 6–12 months — and often thousands and thousands — trying to figure out compliance alone or hiring large consultancies too early.The result?Confusing rules.Slow, expensive consultants.No clear starting point.Clarifi fixes this by giving you a structured, founder-first path through regulation — starting with free tools and clear next steps.
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How Clarifi Works
Clarifi makes regulatory progress simple and transparent — built around how founders actually work.1. Clarity first.
We start by identifying your product’s regulatory pathway — MDR, FDA, EFSA, or MiCA — and where you stand today.2. Practical guidance.
You get clear next steps, document structures, and evidence expectations — no filler, no legalese.3. Lean collaboration.
We focus on short, high-impact support — helping you move forward without long retainers or dependency.4. Continuous alignment.
As your product evolves, Clarifi keeps you aligned with regulators, investors, and your own growth milestones.It’s not about ticking boxes — it’s about giving your innovation the structure it deserves.
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About Clarifi
Clarifi was founded by Stephen O’Rourke, a scientist turned regulatory strategist with hands-on experience across biotech, foodtech, and medtech.After beginning his career in research and biotechnology, Stephen transitioned into regulatory affairs in 2019 — working across EU and US frameworks in areas ranging from Novel Foods and FinTech compliance to medical devices and software. He has since helped multiple startups navigate complex submissions, audits, and market approvals.Before launching Clarifi in Helsinki in 2025, he served as Regulatory & Compliance Lead at Infinite Roots, where he played a key role in the company’s $50M Series B fundraising round, aligning product, risk, and investor expectations.Clarifi brings together that mix of science, strategy, and startup pragmatism— offering founders clear, structured support to turn regulatory uncertainty into progress.You build. Clarifi translates the rules.
Clarifi in the Media
Insights and features on how regulation, innovation, and startup strategy intersect — from MedTech to FoodTech and beyond.Startups don’t just need tech leads: They need an integrator.
Feature for EU-Startups
Read →Confidential by Default? The Transparency Dilemma in Europe’s Novel Foods System.
Feature for Green Queen Media
Read →From Gatekeeping to Guiding: The Case for Collaborative Regulation in Mission-Driven Innovation
White Paper in Collaboration with GCI
Read →Digital Health Meets Red Tape: What Pharma Can Learn from Software as a Medical Device
The role of SaMD in pharma covering regulations, AI/ML risks, compliance, and digital health strategies.
Feature for PharmaNow
Read →Lessons from a €50 million Series B: And why it matters at every startup funding stage
Feature for EU-Startups
Read →What does Gourmey’s regulatory milestone mean for cell-cultivated meat?
Interviewed by FI Global Insights
Read →Why EU Innovators Face Growing Barriers With EU Combination Product Regulation
Interviewed by Medtech Insight
Read →From WHOOP to DiGA: Where the Wellness Line Becomes a Regulatory Minefield
Feature for Test Labs UK Outlook
Read →Guest article: EU novel food delays. Why bureaucracy is choking off food innovation
Feature for AgFunder News
Read →How AI can get your novel food approved faster
Interviewed by FoodNavigator Europe
Read →Apple vs WHOOP: Two Blood Pressure Strategies, Two Very Different Regulatory Journeys
Feature for Test Labs UK Outlook
Read →For interviews, collaborations, or speaking opportunities, contact info(at)clarifi.fi
The Clarifi Ecosystem
Clarifi isn’t a single service — it’s a connected ecosystem built to make complex systems clear.Each division focuses on a specific challenge founders, innovators, or advocates face — from regulation and funding to communication and reform — all united by one idea: clarity drives progress.
Get In Touch
Whether you’re refining your first submission, mapping your regulatory pathway, or just trying to make sense of the rules — let’s talk.Clarifi works best through short, focused conversations that turn uncertainty into clear next steps. No long proposals. No retainers. Just practical guidance when you need it.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.