clarifi.fi
Better Decisions
Under Regulatory Uncertainty
Clarifi helps founders, investors, accelerators, universities, and innovation teams understand regulatory risk before critical development, funding, and commercialization decisions are made.Start with the Regulatory Readiness Test ↓
The Clarifi System
Clarifi combines regulatory intelligence, decision-support tools, and strategic expertise to help innovators identify regulatory challenges earlier and make better-informed development, funding, and commercialization decisions.Designed to support founders, investors, accelerators, universities, and innovation programmes before formal regulatory projects begin, Clarifi helps teams understand regulatory risk, identify critical questions, and make more informed decisions under uncertainty.> Navigator Modules
• Classification Navigator
• Pathway Mapping Framework
• Evidence & Risk Mapping
• Commercialization Readiness Layer> Decision Support Layer> Strategic Translation LayerClarifi sits at the intersection of regulation, evidence strategy, commercialization planning, and innovation ecosystem support.
Who Clarifi Supports
Clarifi supports both innovators and the organisations that help bring innovation to market.Founders & Startups
Understand classification, evidence requirements, and regulatory pathway risk before major development decisions.Universities & Research Teams
Identify translational and regulatory challenges before spin-out, licensing, or commercialisation activities begin.Accelerators & Innovation Programmes
Help startup cohorts identify regulatory blind spots earlier and build more credible development strategies.Investors & Venture Funds
Understand regulatory and evidence risks alongside technical and commercial due diligence.
Regulatory Intelligence Partnerships
Clarifi works with innovators and the organisations that support them, including startups, research teams, accelerators, universities, investors, and innovation programmes operating in highly regulated sectors.These partnerships help organisations identify regulatory blind spots earlier, improve development decisions, and strengthen innovation pathways before significant resources are committed.Areas of collaboration include:• Early-stage pathway strategy
• Regulatory classification
• Evidence and risk planning
• EU, UK, and US market navigation
• Submission and commercialization support
Why Clarifi
Startups don’t fail on regulation late — they fail on decisions made early.Clarifi is designed to make those decisions visible before companies commit major time, capital, and technical resources.
About
Clarifi was founded to help innovators identify regulatory risk earlier, before product, funding, evidence, and commercialization decisions become expensive to reverse.Clarifi was built on a simple observation: many regulatory problems originate long before formal regulatory work begins. Teams often make critical product, evidence, and market decisions before fully understanding the regulatory, evidence, and commercialization implicationsThe goal of Clarifi is to make those decisions more visible, structured, and actionable earlier in the innovation journey.Clarifi is led by Stephen O’Rourke, a regulatory strategist working at the intersection of regulation, commercialization, and innovation ecosystems. Before founding Clarifi, Stephen held Regulatory & Compliance responsibilities at Infinite Roots, contributing regulatory and evidence-planning input during the company’s €50 million Series B financing.He is also selected as an external evaluator for the European Commission’s Health and Digital Executive Agency (HaDEA), providing insight into how innovation is assessed at EU level.His work focuses particularly on how regulatory uncertainty shapes innovation, investment readiness, research commercialisation, and product development strategy.Alongside Clarifi, he contributes to policy and advocacy work in areas such as patient safety, food innovation, and regulatory transparency, applying regulatory thinking beyond compliance into real-world impact.
Selected Writing, Media & Policy Work
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 News
How Teams Use Clarifi
1. Understand what they are building
Assess regulatory classification, intended use, and pathway fit before major development decisions.2. Identify hidden regulatory and evidence risks
Surface regulatory, evidence, and commercialization challenges before significant resources are committed.3. Support strategic decision-making
Help founders, investors, accelerators, universities, and innovation programmes make more informed decisions about development, funding, and market entry.Clarifi helps teams move from uncertainty to structured decision-making before formal regulatory projects begin.Not sure what regulatory challenges lie ahead? ↓
Explore Collaboration
Whether you are a founder validating a concept, an investor assessing risk, an accelerator supporting a cohort, or a university commercialising research, Clarifi can help you better understand the regulatory challenges ahead.