CLARIFI.FI

The Clarifi System

Clarifi is developing a regulatory intelligence system designed to help life science companies navigate classification, evidence planning, and commercialization risk earlier and more systematically.> 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, and commercialization planning.

CLARIFI.FI

Strategic Collaborations

Clarifi works selectively with startups, scaleups, and research teams operating in highly regulated sectors.These collaborations help validate and refine the Clarifi regulatory intelligence platform in real-world development environments - particularly where regulatory classification, evidence strategy, and commercialization planning intersect.Areas of collaboration include:• Early-stage pathway strategy
• Regulatory classification
• Evidence and risk planning
• EU, UK, and US market navigation
• Submission and commercialization support

CLARIFI.FI

About

Clarifi was founded by Stephen O’Rourke, a regulatory strategist working at the intersection of regulatory intelligence, commercialization strategy, and emerging health technologies.His work focuses on structuring regulatory decision-making early — translating complex regulatory frameworks into structured systems designed for real-world decision-making.Before founding Clarifi, Stephen held Regulatory & Compliance responsibilities at Infinite Roots, contributing to regulatory strategy and evidence planning during the company’s €50M Series B.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, and product development strategy in early-stage companies.Alongside Clarifi, he contributes to selected policy and advocacy work in areas such as patient safety, food innovation, and regulatory transparency — applying regulatory thinking beyond compliance into real-world impact.

Policy & Advocacy Initiatives

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 Teams Use Clarifi

1. Assess classification and pathway fit
2. Identify regulatory and evidence risks early
3. Support development and commercialization planningNot sure where your pathway stands yet? ↓

• Explore Your Regulatory Pathway

What We Are Building

Clarifi is developing modular regulatory intelligence tools designed to support early-stage decision-making across life science innovation.These tools help answer:• What am I building (regulatory classification)?
• What pathway am I entering?
• What risks am I creating early?The goal is to make regulatory decision-making more structured, accessible, and scalable during product development and commercialization.

Contact

Whether you are validating a new concept, refining a regulatory pathway, or preparing for commercialization, Clarifi supports both structured decision-support tools and selective strategic collaboration.