MAHs: triage a proposed CMC change
Check whether a proposed change is likely to require Type IA, Type IB or Type II review, identify the source basis to verify, and list the facts still needed before a qualified RA decision.
Use cases
How RA teams use RafiHive
Focused workflows where source-grounded answers save research time without removing expert review.
Regulatory consultants: prepare a first-pass EU summary
Draft a client-ready research outline with source links, legal-weight notes and assumptions separated from confirmed official-source evidence.
Dossier teams: check package completeness
Produce a module-referenced checklist for the procedure type, flag missing materials, and separate source-backed requirements from internal SOP items.
PV and labeling: review SmPC/PIL impact
Compare proposed wording or safety-driven changes against variation and pharmacovigilance obligations, with source-backed caveats for expert review.
Due diligence: surface regulatory red flags
Summarize assumptions, missing evidence, product-information issues and procedure risks from a product scenario before deeper manual review.
Junior RA staff: understand the regulatory basis
Explain a procedure or source hierarchy in plain language while preserving citations, legal weight and the qualified-review warning.