ANGIS
ENTERPRISE

Inspection-ready intelligence for regulated drug development.

Multi-layer governance. Human-reviewed certification. Defensible under scrutiny.

ANGIS Inspect is the enterprise surface of the ANGIS architecture — built for QA, regulatory, clinical operations, and portfolio governance teams who need intelligence that is traceable, reproducible, and auditable out of the box.

THE FRAMEWORK

A multi-layer governance framework.

Every output passes through four independent layers of control before it is certified — and every layer is logged, signed, and independently verifiable.

01

Policy Gating

Configurable policy rules enforce what queries are permitted, what data sources may be touched, and what outputs may be returned — per sponsor, per indication, per engagement.

02

Data Classification

Every data element entering the pipeline is classified by sensitivity, source, and permissible use — the classification travels with the data through every downstream step.

03

Human Review

Human review controls are embedded in the pipeline — not bolted on. Reviewer identity, decision, and rationale are captured as signed attestations on the artifact.

04

Cryptographic Certification

Certified outputs are cryptographically signed and chained to the full governance record. The resulting evidence artifact is independently verifiable — traceable, reproducible, auditable.

Provenance chain · POLICY · CLASSIFY · REVIEW · CERTIFY · Immutable
WHO IT'S FOR

Teams whose intelligence has to hold up.

ANGIS Inspect is built for QA and regulatory teams who need every AI-generated input to their dossiers to be defensible; for clinical operations leaders who need decisions traceable across studies, sites, and sponsors; for portfolio governance groups balancing capital allocation against evolving regulatory signals; and for business development teams preparing inspection-ready data rooms for transactions, partnerships, and licensing negotiations.

Each engagement runs in a per-sponsor isolated context. The governance posture, policy gates, and review board are scoped to the indications and assets we are serving — never shared across sponsors, never cross-pollinated, never reused without explicit authorization.

HOW ENGAGEMENTS WORK

Multi-year. Scoped. Per-sponsor isolated.

We engage on multi-year letters, scoped to a specific set of indications or assets, with a per-sponsor isolated context and a dedicated review board. An optional partner-embedded mode places ANGIS Inspect capabilities directly inside an existing governance or regulatory function — your team, our architecture.

Pricing, scope, and governance posture are all scoped to the engagement. We do not publish rack rates; every engagement is priced against the specific regulatory surface area, the required depth of review, and the governance demands of the sponsor.

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