RafiHive

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RafiHive is an AI agent for EU human-medicines regulatory affairs. It researches regulatory questions, reviews dossier evidence and prepares first-pass drafts, answering only from a reviewed knowledge base of official EU/EEA sources: EMA, the European Commission, EUR-Lex, CMDh, EDQM, eSubmission and national competent authorities. Every claim carries a citation. When the sources do not support an answer, RafiHive says so rather than guessing, and it marks law, guidance, Q&A, draft and superseded material so reviewers see the legal weight behind each statement. Two preset checks run on your own documents: an EU eCTD Module 1 gap check that flags missing dossier evidence, and a Module 1.3 check that reviews SmPC, labelling text and package leaflets against EU and national requirements. Outputs export to DOCX, XLSX, CSV, HTML and Markdown. Built in Germany by EU regulatory-affairs specialists. GDPR-compliant, EU-hosted, and never used for model training.