2 MVPs
Parallel workstreams
SOP / GxP change assist and CTD Phase-1 impact assessment — scoped for demo and validation, not full automation theater.
Case study · Anonymized
GxP SOP change & CTD impact assist
A regional pharmaceutical commercialization / MAH-style partner evaluating sovereign AI for document-heavy quality and regulatory workflows — with human experts remaining accountable.
HITL
Always human-gated
No auto-issuance of controlled SOPs. No auto-filing to health authorities. AI drafts; experts decide.
On-prem
Sovereign posture
Principal and quality documents stay inside an approved environment — illustrative of the Harness deployment model.
Partner identity and confidential principal details are withheld. Outcomes described here are design-partner / MVP framing, not guaranteed regulatory or audit results.
Who (anonymized)
A Southeast Asia–focused commercialization partner supporting foreign principals with product registration, quality systems, secondary packaging–adjacent GDP/GMP activities, warehousing, and distribution. Their teams live in controlled SOPs and multi-country variation work — high expertise, high document load.
Pain
- Change requests that touch many linked SOPs, forms, and appendices
- Manual impact analysis that is slow and easy to under-scope
- Post-approval variations requiring country-specific classification, checklists, and timelines (e.g. Singapore / Malaysia)
- Need for audit trails and confidentiality around principal data
MVP A — SOP / GxP change assist
01
Ingest CR
Change request plus current / historical SOP corpus.
02
Impact map
Primary and secondary impacted SOPs/forms with evidence.
03
Draft
Proposed SOP revision text with citations to CR and source sections.
04
Advise & export
Limited guidance gap advisory + pack for QA review (HITL).
MVP B — CTD / regulatory Phase 1
Focus on change initiation and impact assessment — not full Modules 2–5 authoring or eCTD publishing on day one.
- Understand the principal change vs currently approved information
- Decide whether HA submission is required (per country)
- Classify variation category / code with guidance citations
- Generate documentary checklist and timeline ranges (official vs experience notes clearly separated)
- Export an Impact Assessment pack for RA confirmation
Illustrative success bars for MVP validation include high recall on impacted SOPs, checklist completeness vs gold labels, mandatory uncertainty escalation when evidence is weak, and zero silent submissions.
Why it matters for Ivertiq
- Illustrates the Harness in a second regulated beachhead beyond lab PDF review
- Shows rules-first + LLM-assist design (variation codes allowlisted; no invented filing types)
- Creates a reference pattern for other MAHs and mid-size biotech RA teams in the region
What we do not claim
- Guaranteed health-authority approval or audit pass
- Replacement of QA or Regulatory Affairs judgment
- Full CTD / eCTD automation in the first MVP