Pharma & Life Sciences

The only AI agent stack a regulator can replay.

Built for clinical operations, regulatory affairs, and pharmacovigilance teams that need cryptographically reproducible outputs. Every Sovereign agent produces a 21 CFR Part 11–grade receipt with multi-party attestation and on-demand replay.

Talk to a regulatory engineer Read the receipts spec

Primitives shipped for pharma

21 CFR Part 11 e-record receipts

Every agent run produces an HMAC + Ed25519 signed receipt with a Merkle-chained audit trail. Selective disclosure lets you reveal one field (e.g. final verdict) to an inspector without exposing the rest of the patient record.

Protocol-deviation rubric (pre-built)

An expert-critic rubric specifically tuned for ICH-GCP protocol deviations ships in the core library. The critic flags blockers (eligibility violations, dosing errors, IB version mismatches) before any output reaches a CRA's desk.

Multi-party attestation

Sign each output with sponsor + CRO + investigator HMACs. M-of-N quorum policies. Cross-witness forgery is cryptographically impossible. Strongest possible audit signal for monitoring visits.

Hallucination + citation guard

Verifier layer 6 scores every claim sentence-by-sentence against supplied source documents. Hallucinated citations are dropped; ungrounded sentences are flagged before delivery.

Pre-mapped to EU AI Act + NIST AI RMF + ISO 42001

Every Annex IV control is mapped to a Sovereign capability with audit-ready evidence text. Quarterly attestation letters auto-generate as signed PDFs your CMC + regulatory team can sign and submit.

Three workflows landing on day one

"Draft a Type C meeting briefing book section on our new bioequivalence design."

Agent pulls the latest protocol draft + prior Type B meeting minutes from the trial workspace.
Generates the section against the FDA briefing-book template.
Expert-critic checks for protocol-deviation risk + missing comparator justification.
Multi-party attestation: sponsor regulatory lead + CMC head co-sign before submission.

Briefing-book section + signed receipt + replay-ready audit trail. What took 14 days takes 36 hours.

"Review yesterday's pharmacovigilance signals and draft DSURs sections."

Agent ingests the case-narrative batch from your safety database (E2B R3 import).
Hallucination detector cross-checks every causality claim against the underlying narratives.
Bias auditor flags any demographic-skewed signal language.
Output is co-signed by safety physician + qualified person for pharmacovigilance.

Draft DSUR section + cited evidence map + signed attestation. Reviewer time -70%.

"Run a regulatory-intelligence sweep for FDA letters citing our class of compounds."

Browser-automation agent (Tier-3, admin-only) crawls FDA warning-letter index.
RAG retrieves matched letters by therapeutic-area code + INN.
Receipt timeline view shows what was found, when, and by whom — replay-ready.

Weekly digest with full provenance. Replayable any time a regulator asks 'how did you know?'

Pre-mapped to the controls your QA will ask about

FDA 21 CFR Part 11 — electronic records + electronic signatures

EU Annex 11 — computerised systems

ICH E6 (R3) GCP — investigator + sponsor obligations

ICH E9 (R1) — estimands + sensitivity analyses

EMA Reflection Paper on AI in Lifecycle (2024)

FDA AI/ML Action Plan + Good Machine Learning Practice

EU AI Act Annex IV — technical documentation

ISO/IEC 42001 — AI management system

“Where’s the cryptographic evidence?”

Every other AI platform stops at “explainable.” Sovereign Matrix answers with on-demand cryptographic reproducibility. A regulator pastes a receipt id — Sovereign re-runs the same input through the same agent and reports whether the output drifted. That’s the audit signal pharma’s been waiting for.

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