RafiHive
AI agent for EU pharma regulatory affairs. Every answer cited from official EU/EEA sources, or it tells you it can't.
A startup from Germany.
AI agent for EU pharma regulatory affairs. Every answer cited from official EU/EEA sources, or it tells you it can't.
A startup from Germany.
This page is designed to help you find out whether RafiHive is good and if it is the right choice for you.
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. 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 It marks law, guidance, Q&A, draft and superseded material separately, so a reviewer sees the legal weight behind each statement instead of a flat block of text.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.
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. 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of regulatory questions with known expected sources, covering retrieval hit rate, citation accuracy and retrieval of superseded material.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.
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RafiHive is built specifically for EU pharmaceutical Regulatory Affairs, with answers grounded in reviewed regulatory sources rather than generic web content. It also combines regulatory research with practical workflows such as Module 1 gap checks, packaging and labelling review, and document analysis.
RafiHive focuses on traceability, showing the regulatory sources, assumptions, and evidence behind its answers so RA professionals can review them properly. It is designed to support expert judgement rather than replace it, with a strong focus on real EU RA workflows.
RafiHive is primarily built for Regulatory Affairs professionals working in pharmaceutical companies, consultancies, and service providers focused on EU human medicines. It is especially useful for people working on submissions, variations, lifecycle management, Module 1, labelling, and regulatory research.
RafiHive was created from a simple problem: RA professionals spend too much time searching across fragmented regulatory sources and then verifying whether the information is current and applicable. The goal became to build Regulatory Affairs Factual Intelligence, a support layer that makes regulatory research and first-pass review faster, clearer, and easier to verify.
RafiHive is built as a modern cloud-based SaaS platform using AWS infrastructure, generative AI services, secure document processing, and retrieval-based regulatory knowledge workflows. The platform combines AI models with curated regulatory sources, structured review logic, encryption, and EU-hosted cloud services.
The platform is intended for pharmaceutical companies, Regulatory Affairs consultancies, and other organisations working with EU regulatory submissions and lifecycle activities
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