You lead the commercialisation.
We help you navigate the regulatory decisions.
A focused regulatory pathway assessment for Research to Business teams. Understand which routes are plausible, what could change them, and what your team needs to establish next.
An independent service from Clarifi Oy. Not affiliated with or endorsed by Business Finland or any university.
Regulatory uncertainty changes commercial decisions.
R2B teams have to test markets, develop the technology, protect IP, build partnerships and assess spinout options—often before the final product is defined. Regulatory assumptions can shape every one of those choices.
What are we actually bringing to market?
The product definition, intended use, claims and target customers may point to different regulatory routes.
What evidence will the route require?
Safety, performance and other evidence expectations may affect experiments, budgets, partners and timelines.
Which questions matter now?
Some uncertainties need an early decision. Others can be tested through targeted work without commissioning a full dossier.
Regulatory Pathway Assessment
A concise, source-informed decision brief. Designed to help the team choose its next commercialisation steps—not simply catalogue regulations.
What you receive
- Map of the proposed product, intended use, claims and key assumptions
- Preliminary regulatory qualification or classification and plausible routes for one agreed market
- Evidence expectations, critical gaps and assumptions that could change the pathway
- Implications for product development, customer discovery, partnerships and market entry
- Prioritised 90-day actions, including decisions, suggested owners and unresolved questions
- A 60-minute discussion with the project team
The brief distinguishes established requirements, preliminary interpretations and questions requiring further confirmation. It is not a binding authority determination, legal opinion, notified-body assessment, clinical evaluation or submission.
For technologies where the route to market matters early.
Foodtech & biotech
Novel foods, fermentation-derived ingredients, food applications, claims and market-entry pathways.
Medical devices
Qualification, classification, intended purpose, evidence strategy and selected EU/US route-to-market questions.
Digital health
Software qualification, SaMD, intended use, evidence planning and regulatory implications for product strategy.
Other technologies are considered case by case. Specialist input may be needed and would be agreed separately.
Four steps. Clear scope and decisions.
Scope
Agree the product concept, decision to be supported, target jurisdiction, source materials and exclusions.
Assess
Review supplied evidence and relevant regulatory sources, identifying assumptions and material uncertainties.
Discuss
Walk through the brief, competing pathways, implications and decisions with your team.
Act
Leave with prioritised next steps and a clearer view of where further specialist work is justified.
Regulatory experience, applied to commercialisation decisions.
R2BCC is a focused service offered by Clarifi Oy, an independent Helsinki-based regulatory and commercialisation consultancy founded by Stephen O’Rourke.
Stephen's experience includes EU Novel Food dossiers, medical-device regulatory work and research commercialisation. He also works on a university Research to Business project in a separate employment capacity.
Clarifi engagements are independent of that employment and are accepted only after appropriate availability, confidentiality and conflict-of-interest checks. No university project information or resources are used for client work.
What this service does not do
- Replace the project's Commercial Champion or research team
- Guarantee a regulatory outcome, funding decision or commercial success
- Deliver a full technical, nonclinical or clinical evidence package
- Act as an official Business Finland or university service
Project governance, procurement and funding eligibility remain with the research organisation.
Before you get in touch
Is this only for Business Finland-funded R2B projects?
No. The service is designed around the decisions faced by R2B teams, but other early-stage research commercialisation projects may also be suitable.
Can we purchase this using project funds?
That must be confirmed by your research organisation against the project's funding terms, procurement rules and internal approvals. Clarifi does not determine cost eligibility.
Does this replace our Commercial Champion?
No. It is a bounded external assessment to support the team's decisions. Commercial leadership and project accountability remain with the research organisation.
What if the technology or intended use is still changing?
That can be an appropriate time for an assessment. We identify which assumptions drive the pathway and which questions should be tested before the team commits to a route.
Will our research remain confidential?
Start with a non-confidential summary. Any confidential material is requested only after appropriate confidentiality arrangements and conflict checks. The scope will specify what information is needed.
What regulatory question could change your project?
Send a short, non-confidential outline of the technology, intended market and decision you need to make. We will review fit and, where appropriate, propose a defined scope.
Contact: [email protected].