PHARMA AND LIFE SCIENCES
Governance-native AI infrastructure for drug discovery, clinical, pharmacovigilance, and GxP manufacturing
Constitutional RuntimeWho this is for
Pharmaceutical, biotech, and life-sciences technology leaders, clinical-development groups, regulatory-affairs functions, pharmacovigilance and safety teams, GxP manufacturing operations, and medical-affairs organizations deploying AI where a wrong answer touches a patient, a submission, an adverse-event signal, or a validated system. When a discovery model proposes a candidate, a protocol assistant drafts, a safety-signal engine classifies, or a manufacturing agent acts on a batch record, the constitutional surface belongs upstream of the model.
- Sponsors, CROs, and clinical-development platforms
- Regulatory-affairs, medical-writing, and submission-management groups
- Pharmacovigilance, drug-safety, and signal-detection operations
- GxP manufacturing, quality, and validated-systems programs
- Discovery informatics, translational, and real-world-evidence teams
Capability surface
Constitutional runtime
The PRAXIS 7-Gate pipeline enforces governance on every AI action. It stops when unsure. Evidence is mandatory. Defaults deny rather than guess. Discovery ranking, protocol drafting, safety-signal triage, and manufacturing-agent action inherit this posture by construction, not by policy overlay.
GxP-grade evidence
Every model call, ranking, classification, and generated artifact is recorded to a tamper-evident, SHA-256 hash-chained evidence store aligned with 21 CFR Part 11 and Annex 11 audit-trail expectations. Sealed receipts survive protocol lifecycle, submission cycle, and inspection window.
Patient safety and bounded autonomy
Bounded autonomy enforces separation of duties, deterministic escalation, and hard stops on unsafe generation touching dose, indication, contraindication, or adverse-event coding. Pharmacovigilance workflow, protocol authoring, and medical-communications drafting are enforced at the runtime layer, not left to downstream reviewer discovery.
Regulatory alignment
Deterministic governance maps to FDA (21 CFR Part 11, Part 314, Part 320), EMA Annex 11 and GVP modules, ICH E6(R3) and E2E, GAMP 5 validated-computerized-systems posture, HIPAA and GDPR for clinical data, and emerging AI-in-drug-development guidance. SOC 2 self-certified. ISO 42001 readiness-mapped.
Signal integrity
Pharmacovigilance signal detection, MedDRA coding, and case-narrative generation carry provenance from raw source through model output. Regulator inquiry, internal safety review, and periodic safety-update authoring reach one authoritative record, not reassembled forensics.
Sovereign deployment
On-premise or private-cloud sovereign deployment for sponsors and manufacturers that cannot exfiltrate clinical data, molecule libraries, or batch records to a vendor cloud. Evidence store and constitutional runtime run inside the validated boundary you already trust and inspect.
Where governance meets the pharma stack
Pharma AI applications compound risk when governance is retrofitted. ETHRAEON is designed for the classes of decision where patient safety, regulatory exposure, and validated-systems posture all matter.
- Discovery and translational science. Candidate ranking, target prioritization, and in silico screening pass through the constitutional runtime with sealed provenance for IP, licensing, and downstream regulatory reliance.
- Clinical protocol and submission authoring. Protocol drafting, statistical-analysis-plan generation, CSR sections, and Module 2 summaries carry hash-chained authorship of every model contribution, source citation, and human authority for edit.
- Pharmacovigilance and safety signal detection. Case intake, MedDRA coding, seriousness determination, expectedness assessment, and signal triage carry evidence chains that survive periodic-safety-update-report and regulator-inquiry cycles.
- GxP manufacturing and quality. Batch-record generation, deviation classification, CAPA authoring, and validated-system agent actions record the decision chain from raw process signal to released lot.
Mapped ETHRAEON products
The operational problem in pharma is proving, under GxP and 21 CFR Part 11, that a claim-bearing or safety-signal determination was governed: obligations identified, mapped to policy and control, approved by a named authority, and replayable. Three ETHRAEON products map directly onto that problem and run as one governed workflow. The concrete deliverable is a claims-evidence receipt plus a GxP and 21 CFR Part 11 approval-and-attestation trail.
Compliance Engine
Live runtime, available by subscription. For a sponsor it captures the 21 CFR Part 11, Annex 11, GxP, and FDA pharmacovigilance obligations that bind a discovery-ranking, protocol-drafting, or safety-signal action and maps each to the quality system. It records the obligation, the obligation-to-policy-to-control mapping, and each evidence linkage through the governed runtime; every evidence linkage returns a SHA-256 evidence node. It runs EU AI Act risk-class detection, GDPR data-lineage tracing, cross-border data-movement flags with provenance, and configurable rule packs per jurisdiction, and exports a regulator-ready audit log. It never issues, claims, or implies certification; sign-off remains a human authority act.
Governance Dashboard
Live runtime, available by subscription. For the quality and pharmacovigilance function it surfaces live enforcement state and the preventative halt log with rationale for QA leadership and the audit committee. It is the composition and observability layer over the governed-decision products: a live constitutional-rule enforcement panel, per-model and per-agent policy-state visibility, a preventative halt log with rationale, per-tenant rule scoping, and a read-only board or audit-committee view, white-label on request. It reads governed-runtime state and never overrides a constitutional or authority boundary.
GENTHOS 3.0
Refinement, quality-assurance, and governance-safe output engine. For the submission or label claim it refines and quality-assures the governance-safe artifact before a reviewer sees it, with every step on the Part-11-aligned evidence chain; it never approves the claim. It executes only after upstream routing, within constitutional bounds, and writes each refinement step to the append-only evidence chain. It never performs the sovereign decision, the valuation, or the arbitration; SOC 2 is self-certified and ISO 42001 and EU AI Act alignment are readiness-mapped, not certified.
Deliverable: a claims-evidence receipt plus a GxP and 21 CFR Part 11 approval-and-attestation trail for a submission, label, or safety-signal action. It maps against 21 CFR Part 11 and Annex 11 audit-trail expectations, GxP, and FDA pharmacovigilance obligations, and it is produced by the governed runtime at the moment of the action, not reconstructed under review pressure afterward.
The regulatory and safety call stays with the qualified sponsor and QA function; the runtime produces and governs the evidence.
Proof surface
ETHRAEON runs its own operations under constitutional governance. 300 plus production surfaces, 700 plus governance directives executed and evidenced, a hash-chained evidence store, and a substrate registry that reports live status. The infrastructure is the demonstration.
Engagement
Pharma engagements start with a governance briefing scoped to your therapeutic area, regulatory posture, and current AI deployment surface across discovery, clinical, safety, and manufacturing. The briefing produces a written architecture assessment and a deployment path proposal. From there: pilot, evidenced production integration, or sovereign private-cloud install inside a validated environment.
Portfolio anchors
ETHRAEON is a constitutional runtime and evidence control layer. Portfolio posture: 16 filed U.S. provisional applications / 75 technical specifications / 9 families. Public claims are calibrated. AGI-class and ASI-class positioning is architectural, not an achievement claim.