Assurance
Dossier health check
Identify gaps and inconsistencies before inspection or major variation work.
Bring your dossier back under control. Instantly.
AI-powered regulatory intelligence that identifies gaps, classifies variations, and drafts Module 3 updates — in hours, not weeks.
Built for Regulatory Affairs. Designed for compliance. Trusted by experts.
Public information site — sign-in and analysis run in your organisation’s application instance.
Your dossier is not what you think it is.
Most Marketing Authorisation Holders are operating with legacy dossiers no longer aligned with manufacturing reality, undocumented or partially implemented changes, increasing regulatory scrutiny, and significant time spent on manual gap analysis.
Every variation becomes harder because:
- You don’t fully trust your baseline.
- Legacy structure and partial change history slow every submission.
- Inspection risk grows when the approved state and the plant no longer match on paper.
This is not a documentation problem. It’s a regulatory risk problem.
RegAIDossierIQ
A secure AI platform that compares your registered Module 3 dossier against your current manufacturing source data and delivers a complete, submission-ready variation package — with regulatory-grade classification and citations, not generic text.
How it works
From ingest to submission-ready outputs — structured, traceable, and aligned with the EU variations framework.
Step 1 — Ingest
Upload: your current registered dossier (Module 3) and the latest source documents from manufacturing.
Step 2 — Gap analysis
AI performs a structured comparison: every deviation from the approved state, with evidence-backed differences.
Step 3 — Regulatory classification
Each change is classified (Type IA / IAIN / IB / II), assigned the correct EU variation code, and supported with regulatory citations.
Step 4 — CTD authoring
Automatically generates updated Module 3 sections, clean and tracked-change versions, in regulatory-grade language.
Step 5 — Submission package
Outputs: change list for eAF, supporting document map, and an audit-ready report — fully aligned with EU variations expectations.
Complete regulatory output package
What you receive in a single AI-assisted run:
- Clean CTD sections (ready for submission)
- Tracked changes (review-ready)
- Variation classification and codes
- eAF-ready change summary
- Supporting document manifest
- Full audit trail and decision log
Reduce weeks of work to hours
What normally takes two to four weeks of senior RA time can be compressed into a single assisted run — with human sign-off on every decision that matters.
Eliminate regulatory blind spots
- No missed changes or undocumented deviations.
- Less “hidden” compliance risk between approved and actual state.
- Every decision cited and traceable — not free-form automation.
This is not automation replacing Regulatory Affairs. AI does the heavy lifting; experts make the final decision.
“The first AI platform designed to think like a Regulatory CMC reviewer.”
Built for regulatory environments
Trust comes before technology. Pharma buyers care about compliance, defensibility, and inspection readiness — not model names.
- Designed so data stays within your controlled environment (deployment-specific).
- Full audit trail for every classification and drafting decision.
- Alignment with EU variations regulation, ICH M4Q / CTD structure, and EMA expectations on proportionate use of AI.
Use cases
Where teams get the most leverage from a structured dossier baseline.
Readiness
Variation readiness
Establish a clean, trusted baseline before the next round of submissions.
Operations
Tech transfer / CMO changes
Rapidly assess impact and required variations when manufacturing moves or scales.
Portfolio
Post-merger / acquisition
Reconcile legacy dossiers and sources at scale with consistent methodology.
This is just the beginning
RegAIDossierIQ is the foundation for multi-region regulatory intelligence, change-control-driven automation, and full lifecycle regulatory management — always with regulatory augmentation, not “black box” replacement of your experts.
Know exactly where your dossier stands.
Run a secure AI-powered dossier analysis and receive a gap report, variation roadmap, and draft CTD updates — scoped to your deployment and governance model.
Request a demo