If you've ever worked in regulatory affairs, you know the quiet dread: a rule changed somewhere, you're pretty sure you saw it, but now you can't find where, and the deadline doesn't care.
Updated September 11, 2026 to reflect RafiHive's current workflows.
RAFI means Regulatory Affairs Factual Intelligence. RafiHive supports EU pharma regulatory professionals with research, dossier evidence review, and first-pass drafting, using official EU/EEA sources and the private documents they choose to provide. Qualified professionals review the evidence and make the final decisions.
Regulated work has a particular kind of pressure. It's not just that there's a lot of information—it's that the information keeps moving, and being wrong has consequences. A requirement shifts in one market. A guidance document gets a new revision. Something you cited last quarter no longer says what you remembered. And the whole time, the thing that actually protects you is being able to point at the source and say here, this is why.
In regulated work, an answer you can't trace back to its source isn't an answer. It's a liability with good grammar.
The problem isn't finding text. It's keeping the thread.
Plenty of tools can hand you a confident paragraph. That's the easy part now, and honestly it's part of the trap. AI is very good at producing language that sounds right, which is exactly the wrong thing to lean on when a statement can be perfectly clear and still cite the wrong source, miss a market-specific condition, or quietly flatten an exception that matters.
RafiHive keeps source links, assumptions, and evidence gaps alongside its first-pass answers. That gives the reviewer a basis for checking what applies to a particular procedure, market, or dossier, rather than treating a generated paragraph as a final decision.
From research to dossier checks
- Regulatory research and drafting: ask questions, review private documents, and export first-pass work with sources to verify.
- EU eCTD Module 1 gap checks: use a declared inventory or attached dossier evidence to identify present, missing, unclear, and not-applicable items with reviewer actions.
- Module 1.3 packaging and labelling checks: review SmPC, labelling text, and package leaflet consistency alongside EU and declared target-market requirements.
The dedicated Module 1 and packaging checks are Team workflows. They provide a first pass for expert review, not a final submission decision. Packaging checks do not assess artwork, translation quality, or legibility.
Who this is really for
RafiHive is built for the people who carry the responsibility, not the people who want a demo. That means:
- EU pharma regulatory affairs teams and marketing authorisation holders reviewing requirements across markets.
- Specialists who need to revisit a decision months later and reconstruct exactly why they made it.
- Small teams doing the work of large ones, who can't afford to re-research the same rule twice.
- Regulatory consultants and junior RA staff who need cited research and clear review steps.
Why it isn't just an AI wrapper
Here's the part we're stubborn about. It would have been faster to wrap a language model in a nice interface and call it regulatory intelligence. We didn't, because the hard knowledge in this field doesn't live in a generic model—it lives in the people who've done the work and know where the edge cases hide.
So regulatory affairs specialists sit with the engineers and shape the actual product: which sources count, how a workflow should behave, what "good" looks like, where the system should show uncertainty instead of smoothing it over. Domain expertise isn't a layer we paint on at the end. It's part of the architecture. The specialist keeps the judgment; RafiHive just makes that judgment faster to reach and easier to prove.
That's the whole idea—use AI as leverage, not as the final authority. Turn scattered regulatory information into intelligence you can actually stand behind.