EU human medicines regulatory intelligence

RafiHive

AI-assisted EU regulatory research for pharma RA teams, cited from defined official sources and built for qualified human review.

Official-source citationsExpert review built in

EU processing

Application data (accounts, conversation history, generated exports) is stored and processed in the EU (AWS eu-west-1).

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

Five steps, and a list of what never happens.

  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.

Fragmented source landscape

Regulatory answers need traceable evidence, not confident guesses.

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.

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.

MAHs and pharma teams

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

Junior RA staff

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

Source-first assistant

Ask in natural language. Get cited RA outputs ready for expert review.

Retrieve

Prioritizes official EU/EEA regulatory sources before web fallback.

Reason

Combines global RA instructions, task prompts, recent thread history and KB chunks.

Generate

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

Live today

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.

First-pass review only · no final compliance decision
UnclearMajor
EU regional administrative evidence
Evidence found
No explicit supporting file identified.
Source
Exact official-source section required.
Reviewer action
Confirm applicability and attach the current evidence.

Public proof

Show the evidence trail before asking buyers to trust the answer.

A serious RA workflow needs source hierarchy, confidence, assumptions and a clear human-review boundary. RafiHive answers are structured around that review trail.

Illustrative sample, shortenedHuman review required

Question: We want to change the manufacturing site for finished product batch release. What variation type may apply?

Practical answer

RafiHive would treat this as preliminary triage, not a final classification. It would identify the procedure route, the exact site role, product scope and supporting evidence needed before comparing the change against the variations regulation, the Commission classification guideline and route-specific EMA or CMDh guidance.

Legal weightLaw, guidance and procedural advice separated
ConfidenceHigh for source scope, lower where facts are missing
Review warningConfirm route, current source version and dossier evidence

Sources used in this answer

  • Regulation (EC) No 1234/2008 - legal framework for variations.
  • Commission Guidelines (C/2025/5045) - variation category detail.
  • EMA post-authorisation guidance or CMDh MRP/DCP guidance - route-specific procedure handling.

Standard notice: output is decision support only and must be reviewed by a qualified regulatory professional before use.

Trusted source hierarchy

Defined source coverage, not a vague "EU/EEA sources" claim.

99 explicitly reviewed source documents are listed from the manifest. Live indexing is tracked separately; gaps stay visible until review is complete.

EUR-LexEuropean CommissionEMACMDh/HMAEDQMeSubmissionSPOR/PLMICH

Limitations

AI-assisted, expert-reviewed, never autonomous regulatory advice.

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.

Common workflows

Built for the RA problems that show up on Monday morning.

MAHsTriage proposed CMC changes and identify likely variation evidence to review.
Regulatory consultantsPrepare first-pass EU regulatory summaries with source links for client checking.
Dossier teamsBuild procedure-specific checklists for module and application-form completeness.
Due diligenceExtract regulatory red flags, assumptions and missing evidence from a product scenario.
PV and labelingCompare proposed SmPC/PIL wording changes against variation and safety obligations.
Junior RA staffExplain the regulatory basis behind a procedure with citations and review warnings.

Pricing

Start with trial questions. Move to a plan procurement can understand.

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
  • 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.

  • Everything in Individual
  • EU eCTD Module 1 gap analysis
  • Shared private team knowledge base
  • Shared billing across seats
  • Organization profile
  • 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

FAQ

Questions before you begin.

Which sources are used?

The public source coverage page lists loaded documents from the current manifest, including gaps.

Are prompts used for model training?

No. Customer inputs and outputs are processed to provide the service and are not used to train foundation models.

Does RafiHive replace RA experts?

No. It supports research and drafting; qualified professionals must review outputs.

What happens when evidence is missing?

The assistant is instructed to say what is missing rather than smooth over gaps with unsupported claims.

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.