RegAIDossierIQ AI regulatory consultant

RegAIDossierIQ

The first AI regulatory consultant

Regulatory AI that finds gaps, classifies variations, and authors CTD updates automatically

Reduce dossier remediation projects from months to days.

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Public information site — analysis runs in your organisation’s application instance.

What it actually does

From change control to a submission-ready package — in one structured path.

  1. Change control

  2. Gap analysis

  3. Variation classification

  4. Regulatory strategy

  5. CTD update

  6. Submission package

Your dossier is not what you think it is.

Most Marketing Authorisation Holders operate with legacy dossiers no longer aligned with manufacturing reality — undocumented changes, partial history, and rising inspection risk.

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.

Before vs after

What a senior RA remediation project looks like today — and with RegAI.

Traditional process

12 weeks

  • 6 RA staff involved
  • Manual dossier review
  • Excel trackers and email chains
  • Multiple external consultants

With RegAI

~1 day

  • Complete gap analysis
  • Variation classification
  • Draft CTD updates
  • Experts retain final sign-off

This is not automation replacing Regulatory Affairs. AI does the heavy lifting; experts make the final decision.

Use cases

What regulatory teams buy — concrete workstreams, not abstract features.

Dossier gap analysis

Find all differences between the registered dossier and the current manufacturing process.

Change control assessment

Automatically identify regulatory impact and required filings for each change.

Variation classification

Determine Type IA, IB, II — including grouping and worksharing strategy.

Module 3 authoring

Generate CTD updates automatically in regulatory-grade language.

Tech transfer

Identify all regulatory actions before transferring a product to a new CDMO.

Who uses it

Built for the functions that own the dossier and the risk.

  • Regulatory Affairs
  • CMC
  • Regulatory Operations
  • Quality Assurance
  • Pharmacovigilance
  • Clinical Development

Example case study

Illustrative example — how a single assisted run turns manufacturing drift into a variation package.

Product

Solid oral tablet

Problem

Manufacturing process changed over 10 years.

Input

Module 3 + master batch records (MBRs)

Output

27 gaps identified
Type II variation strategy
P.3.3 updated CTD section
4 hrs assisted run time

Plus supporting document list — ready for internal review and eAF workflows.

The regulatory AI platform

Module 3 is the foundation — not the ceiling. RegAI is built as a multi-domain regulatory intelligence platform.

Today

  • Gap analysis
  • Variations
  • CTD updates

Coming

  • IMPDs & IBs
  • MAAs & INDs
  • Change controls
  • QA deviations & CAPAs
  • PV assessments

“An AI that thinks like a senior Regulatory Affairs CMC consultant.”

Built for regulatory environments

Trust comes before technology. Pharma buyers care about compliance, defensibility, and inspection readiness.

  • 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.

Security & privacy detail

Know exactly where your dossier stands.

Run a free dossier health check — receive a scoped gap view, variation roadmap, and path to draft CTD updates under your governance model.

Run a free dossier health check Request a demo