How it works
AI supports research and drafting. Each brief has qualified human review before release.
01
Confirm scope
We agree the question, the required inputs, the fixed fee and the start date before any paid work begins.
02
Research and review
We develop our own assessment from agreed non-confidential device facts and public regulatory sources, without seeing your existing strategy. It is reviewed before release.
03
Deliver your brief
You receive the written Regulatory Pathway Brief, then we discuss the findings and open questions with you. You compare it with your existing strategy privately.
Common questions
- We already have a regulatory adviser. Does this replace them?
- No. Keep working with them. The brief gives you a second opinion to compare privately with their work.
- Do we need to send you our existing strategy?
- No. Falcr builds its view independently and does not see your strategy, so it does not audit or comment on it. You compare the two privately.
- What inputs do you need?
- Agreed non-confidential device facts, confirmed after scoping. Do not send technical files through the enquiry form.
- When does the two-business-day delivery start?
- On the start date we agree with you after scoping. The written brief is due two business days from that date.
- What is not included?
- Submission preparation or filing, representation before an authority, quality management system work, testing or clinical work, additional jurisdictions and any guaranteed outcome.