RafiHive

RAFI · Regulatory Affairs Factual Intelligence

Source-grounded AI for EU regulatory affairs.

Research EU regulatory questions, review dossier evidence and catch Module 1 and labelling gaps — with citations to official sources and a clear human-review boundary. You bring the expertise, assess the evidence and make the decisions.

Source-grounded first passQualified RA sign-off requiredBuilt in Germany · EU-hosted

What an answer looks like

Every answer names its legal basis and its limits.

The classification annex was restructured in January 2026. An answer that still quotes the 2013 code looks right and is wrong, which is why the code and its source are shown, not summarised.

Full sample output How answers are tested Why the code changed in 2026
Illustrative sample, shortened

Question: We want to add a new site for finished product batch release. What variation type may apply?

Adding a site responsible for batch release is a Type IA IN variation under code Q.II.b.2(c)(1) where the site does not also take over batch control testing, and Q.II.b.2(c)(2) where it also tests with physicochemical or microbiological methods. It moves to Type IB under Q.II.b.2(c)(3) where the site tests a biological finished product with a biological, immunological or immunochemical procedure.

Sources used in this answer

  • Commission Guidelines C/2025/5045, Annex, code Q.II.b.2 — change to batch release arrangements and batch control testing of the finished product, conditions 1–5 and documentation 1–6.

Measured before every release · golden-set run, 2026-09-07

Expected-source retrieval100%
Fabricated citations0
Superseded or unapproved sources retrieved0
Strict full-case benchmark12 / 16

Fragmented source landscape

Every answer has to survive a reviewer asking where it came from.

EMA, EC, EUR-Lex, CMDh, EDQM, eSubmission, SPOR and national authority guidance change over time.

Manual research creates inconsistent outputs across consultants, managers, and specialist teams.

Every answer needs a clear distinction between law, guidance, Q&A, draft and superseded material.

How RafiHive works

Retrieve

Searches reviewed official EU/EEA sources by default. Optional web search stays off unless you switch it on for a conversation.

Assess

Produces source-grounded first-pass answers for qualified review.

Generate

Prepares tables, reports, DOCX, XLSX, CSV, Markdown and HTML outputs.

Our mission is to give RA professionals more time to apply their expertise. About RafiHive · How the Regulatory Affairs AI Agent retrieves, assesses and cites

Checks you can run today

Cited first-pass checks for EU submissions.

Find EU Module 1 gaps before validation does.

Set the submission scope, attach the dossier evidence you have, and get a cited first-pass deficiency list — each finding marked present, missing, unclear or not applicable, with the reviewer action it needs. It runs from a declared inventory too, so you can try it without uploading anything.

Team plan · first-pass review only · no final compliance decision
UnclearMajor
1.6 Environmental risk assessment
Evidence found
No explicit supporting file identified.
Source
EU Module 1 eCTD Specification v3.1 (June 2024), section 1.6; Directive 2001/83/EC, Art. 8(3)(ca).
Reviewer action
Confirm applicability and attach the current evidence.

Who it is for

One RA workflow, different trust needs.

Individual RA professionals

Fast source-grounded research, explanations and first-pass drafting support.

Regulatory consultants

Client-ready research outlines, source links and assumption logs for review.

Prepare first-pass EU regulatory summaries with source links for client checking.

MAHs and pharma teams

Controlled source traceability, shared review discipline and procurement-ready trust material.

Triage proposed CMC changes and identify likely variation evidence to review.

Junior RA staff

Training-style explanations that keep citations, limits and human review visible.

Explain the regulatory basis behind a procedure with citations and review warnings.

Dossier teams

Build procedure-specific checklists for module and application-form completeness.

Due diligence

Extract regulatory red flags, assumptions and missing evidence from a product scenario.

PV and labelling

Compare proposed SmPC/PIL wording changes against variation and safety obligations.

Worked use casesVariations, dossier completeness, labelling and due diligence, step by step.

Trust and data handling

Named sources, private documents, stated limits.

EU processing, GDPR

Operated from Germany under the GDPR. Application data (accounts, conversation history, generated exports) is stored and processed in the EU (AWS eu-west-1, Ireland).

No model training

Questions and answers are processed to generate your response and are not used to train foundation models. The same applies to documents you upload.

Encrypted and workspace-isolated

Encryption in transit (TLS) and at rest, and a person outside your team cannot browse, search, attach or receive citations from your documents.

Delete anytime

The uploader can remove a document. RafiHive stops using it in answers immediately and completes removal from private storage and searchable knowledge.

What happens to your document

  1. 01Encrypted upload

    Your browser sends the file straight to EU storage over TLS with a signed link that expires in minutes. It is encrypted at rest on arrival.

  2. 02Validation

    The file type, declared size and content are checked before the file can be used, and the content must match what the browser declared. A file that fails is deleted from storage, not kept.

  3. 03You choose where it can be used

    Keep a file inside one conversation, or deliberately make it available to your private team or personal knowledge.

  4. 04Used to answer, with citations

    The file is retrieved only to answer the questions you ask, alongside the official-source knowledge base, and findings cite what they came from.

  5. 05You delete it

    The uploader can remove a document. RafiHive stops using it in answers immediately and completes removal from private storage and searchable knowledge.

What does not happen
  • Your documents are not used to train foundation models — not ours, not the model provider's.
  • Your documents are never sent to the optional web search, and private document locations are never shown in answers.
  • Your documents are not moved outside the EU (AWS eu-west-1).
  • Your documents are not visible to another customer, another team, or a team member you did not share them with.
  • Nothing is uploaded at all unless you attach it — the gap check runs from a questionnaire if you prefer.

Source hierarchy: 55 EU/EEA documents and 76 ICH guidelines

Reviewed source set: 55 EU/EEA documents and 76 ICH guidelines, each listed by name with its authority and approval status. Last reviewer check: 2026-09-30. Documents still awaiting review stay visible as gaps rather than being answered from.

EMAEUR-LexEuropean CommissionCMDhEDQMeSubmissionICHHPRAMHRA
View source coverage

Limitations: a qualified person signs off, the software does not

RafiHive provides AI-assisted regulatory research and drafting support. Outputs must be reviewed by qualified regulatory professionals before use in submissions, authority communication, client advice, or business-critical decisions.

  • Does not replace qualified RA professionals or legal advice.
  • Does not make final submission, classification or authority-response decisions.
  • Does not guarantee EMA, NCA or client acceptance.
  • Does not validate company SOP compliance unless those materials are provided and reviewed.
AI governance and human review

Latest regulatory insights

Current changes and practical analysis for EU RA teams.

Annex II and the new master files: the EU dossier is getting modular, not simpler29 September 2026 · The Council adopted the EU pharma package on 28 September 2026, and on 6 October the Pharmaceutical Committee discusses the first implementing work on dossier requirements and master files. The new Directive lets applicants rely on EMA-certified active substance, additional quality and platform technology master files. That cuts duplicate assessment. It also moves the hard part of regulatory work from writing the dossier to knowing what the dossier depends on.EU variations in 2026: what changed and what regulatory affairs teams need to check17 September 2026 · The revised Variations Regulation has applied since 1 January 2025. The new Commission Variations Guidelines have applied since 15 January 2026. New classification codes, transition rules, Type IA annual-update cycles and updated submission tooling are now part of everyday work rather than a future change.EU pharmaceutical legislation reform 2026: what regulatory affairs teams need to prepare for29 September 2026 · The EU is replacing the pharmaceutical framework it has worked under since 2004. Political agreement came in December 2025, the Council adopted it on 28 September 2026 and Parliament's vote is pending, and a transition period to 2028 is planned while the Commission, EMA and national authorities build the rules, guidance, procedures and systems. For RA teams, implementation has started before the law is in the Official Journal.
View all insights

Pricing

Try it free, then buy a plan your procurement team can read.

Free trial

0 EUR

Up to 3 submitted questions total.

  • 3 source-grounded questions
  • Private document analysis in one chat
  • Full citations to official EU/EEA sources
  • Exports: Markdown, HTML, CSV, DOCX, XLSX
  • Free Module 1 and Module 1.3 scope briefs
  • No card required

Individual RA

49 EUR/ month per user

For a single regulatory-affairs professional.

  • Unlimited questions
  • Private document analysis in one chat
  • Full citations and answer confidence signals
  • Thread history and contextual follow-up questions
  • All export formats
Best for teams

Team

59 EUR/ seat per month

Per seat with shared billing. Minimum 5 seats — unused seats stay available.

  • Everything in Individual
  • EU eCTD Module 1 gap check
  • EU Module 1.3 packaging & labelling check
  • Regulatory Readiness: eCTD v4.0 assessment and tracking setup
  • Shared private team knowledge base
  • Invite and remove members by email
  • Shared billing across seats (from 5)
  • DPA and procurement answers on request

Enterprise

Custom

For controlled pilots, procurement review and private source workflows.

  • Everything in Team
  • Security and AI governance pack
  • Private source scoping
  • Audit-log and export requirements review
  • Workflow demo for RA, QA, IT and compliance
Compare every plan feature

FAQ

Questions before you begin.

Which regulatory sources does RafiHive use?

RafiHive retrieves from a defined knowledge base of official EU/EEA regulatory sources and ICH guidelines. The public source coverage page identifies documents, versions, review and indexing status, and known gaps. A catalogued source is not necessarily available for retrieval yet.

Does RafiHive use customer prompts for model training?

No. RafiHive processes customer inputs and outputs to provide the service and does not use them to train foundation models. The data handling and security page describes processing, access and document deletion.

Does RafiHive replace RA experts?

No. RafiHive is built to support RA professionals, not replace them. It assists with research, evidence review and drafting; your expertise and judgment guide every final decision.

What does RafiHive do when regulatory evidence is missing?

RafiHive is instructed to identify missing evidence and distinguish assumptions from supported findings. When retrieval finds insufficient support, it returns a not-found result. AI output can still be wrong; a qualified regulatory professional must verify the sources and final decision.

Review regulatory evidence faster.

Your questions and data stay secure and server-side, processed in the EU, and answers are traceable to defined sources for qualified expert review.