RafiHive Reviews & Product Details

RafiHive is an AI agent for regulatory affairs teams working on EU human medicines. It researches regulatory questions, reviews dossier evidence and prepares first-pass drafts, so RA professionals spend less time locating sources and more time applying judgement. Answers come from a reviewed knowledge base of official EU and EEA material: EMA, the European Commission, EUR-Lex, CMDh, EDQM, eSubmission and national competent authorities, alongside ICH guidelines. Every source is listed publicly with its version and review status, and known gaps in coverage are published alongside them. How it differs from a general AI assistant Every substantive claim carries a citation. When the knowledge base and your own documents do not contain sufficient evidence, RafiHive reports that rather than generating a plausible answer. It marks law, guidance, Q&A, draft and superseded material separately, so a reviewer sees the legal weight behind each statement instead of a flat block of text. Answers carry confidence, stated assumptions and an explicit human-review boundary. Preset dossier checks The EU eCTD Module 1 gap check takes your submission scope and either the evidence you attach or a declared inventory, and returns a cited deficiency list. Each item is marked present, missing, unclear or not applicable, with a severity, the source that requires it and the action a reviewer should take. The Module 1.3 packaging and labelling check reviews SmPC, labelling text and package leaflet together. EU-wide requirements are checked once, then national requirements run once per target market, quoted from the published CMDh blue box document. Mismatches between the three documents are reported separately. Findings and answers export to DOCX, XLSX, CSV, Markdown and HTML for your own review trail. Security and governance RafiHive is designed, built and operated in Germany by a team of EU regulatory-affairs specialists and software engineers. Application data, uploaded documents and AI inference stay inside the EU. Personal data is processed under the GDPR. Documents are encrypted in transit and at rest, isolated to your workspace, never used to train foundation models, and deletable at any time. Accuracy is measured before every release against a golden set of regulatory questions with known expected sources, covering retrieval hit rate, citation accuracy and retrieval of superseded material. Current results and the method behind them are published. RafiHive supports RA professionals rather than replacing them. It does not submit to EMA, national authorities, CESP or IRIS, does not make final classification or submission decisions, and does not give legal or medical advice. Every output requires qualified regulatory review.