Typical questions
- What regulatory pathway applies in this market?
- How are comparable products classified?
- Which Notified Bodies are designated for this device or IVD scope?
- What does a regulatory change mean for our product?
- How does the EU approach compare with the United States or China?
- What evidence are regulators or assessors expecting for this technology?
- What does a new policy mean commercially?
Required inputs
- The decision or question to be answered
- Relevant product or company context
- Target market
- Deadline, if the question is time-sensitive
- Any existing internal analysis or assumptions that should be tested
What Fabola does
We define the question narrowly, identify primary regulatory and policy sources, triangulate secondary evidence where useful, and produce an answer designed to support a real decision rather than a generic literature summary.
Deliverables
- Regulatory intelligence memo
- Source list with links
- Market-entry or pathway analysis
- Comparative regulatory analysis where relevant
- Board or management briefing
- Clear recommendation and next-step options
Price
Focused regulatory answer
SEK 19,000
One narrow question with limited source set and concise written answer.
Standard regulatory intelligence memo
SEK 29,000
Typical assignment: defined question, primary-source research, analysis, written recommendation and one review meeting.
Complex comparative analysis
SEK 39,000–59,000
Multiple jurisdictions, extensive market mapping, several product pathways or a materially broader evidence base.
All prices are in SEK and exclude VAT.
Delivery time
Typical delivery: 5–10 business days. Broader comparative assignments are usually delivered within 2–3 weeks.
Completion point
The assignment is complete when the agreed research question has been answered in writing, sources have been provided and the recommendation has been discussed in one review meeting.
Exclusions
- Formal legal opinion
- Complete product-specific conformity assessment
- Full technical-documentation development
- Ongoing monitoring unless separately commissioned
If further work is needed
Depending on the outcome, no further Fabola work may be required. Where the analysis identifies a defined regulatory project, it can be scoped as a separate piece of work.
Frequently asked questions
Can you answer a single regulatory question without a retainer?
Yes. That is the purpose of this service. A standard regulatory intelligence memo is normally SEK 29,000 and is scoped around one defined decision.
Can you compare EU, US and China pathways?
Yes. Comparative work is particularly useful when a company is deciding market sequence, evidence reuse or where to establish its first regulatory pathway.
Do you use primary sources?
Yes. Fabola prioritises legislation, regulator and competent-authority materials, official databases, standards and other authoritative sources, with secondary evidence used where it adds context.
Can you monitor a regulatory development after the memo is delivered?
Yes, but ongoing monitoring is outside the fixed memo scope and is quoted separately if needed.
Related services
Classification and conformity pathway
Is my product a medical device or IVD, what class is it, and what do I need to do to place it on the EU market?
EU AI Act + MDR / IVDR
How does the EU AI Act interact with the MDR or IVDR for our product?
Clinical and performance evidence
What evidence do we actually need to support our medical device or IVD?
Ready to define the work?
Tell us what the product is, where the project stands and the regulatory question you need answered.
We will confirm whether this service fits, or point you to a better starting point.
The first conversation is free and carries no commitment.