July 2026 — US policy on high-risk life sciences research rewritten, the third revision since 2024 EU Biotech Act — extends biosecurity duties from funders to companies and laboratories EU 2021/821 — record-keeping obligations cover intangible technology transfer, not only goods 21 CFR Part 11 — audit trails and e-signature required on regulated electronic records Rule packs are dated — every assessment records the framework version in force on the day
AI agents for regulated review

Screen every document.
Prove every decision.

Every finding cites its passage, against a dated rulebook. Your expert still decides.

From an engagement

What the expert missed

A 247-page submission, reviewed twice.

Human review
2
findings
+5
AI review
7
findings
Document size
247 pages
Time to signed decision
8 hours 20 minutes
  • One critical export-control issue detected
  • Evidence chain shown
01 — Architecture

Agentic pipelines, running on your premises

Pinned and versioned, so the same document returns the same assessment years later.

Documents enter the pipeline inside your tenant, are mapped to a dated rule pack, and leave as a cited evidence pack routed to a named reviewer. Proposals, protocols, technical files YOUR TENANT — DOCUMENTS NEVER LEAVE 01Read 02Map 03Cite 04Record rule pack v1.4.2 dated · signed · pinned Evidence pack Findings, each cited Framework version applied Full audit record Routed to a named reviewer, who signs Documents enter the pipeline inside your tenant, are mapped to a dated rule pack, and leave as a cited evidence pack routed to a named reviewer. Proposals, protocols, technical files YOUR TENANT — DOCUMENTS NEVER LEAVE 01Read 02Map rule pack v1.4.2 dated · signed · pinned 03Cite 04Record Evidence pack Findings, each cited Framework version applied Full audit record Routed to a named reviewer, who signs
02 — What it produces

An agentic assessment

Input — submitted proposal 34 pages

§ 2.1  Proposed work The programme will construct chimeric viruses carrying surface glycoproteins from bat-derived sarbecoviruses on a laboratory backbone, and passage the resulting constructs through a humanised animal model to characterise replication kinetics.

§ 2.4  Containment All work involving live virus is conducted under BSL-3 containment, with challenge studies performed in the partner facility.

§ 5.2  Prior work (excluded from assessment) Previously the group completed a serological survey using archived human sera…

Intake — new submission queued
File
proposal.pdf · 34 pages
Rule pack
Biosecurity Screening
Version
v1.4.2 dated · signed · pinned
Runs in
Your tenant
The document never leaves your environment. The version in force is recorded before anything runs.

Illustrative example using publicly described policy criteria. No customer document is reproduced.

03 — Rule packs

Five regulated reviews

Each produces the record its reviewer writes by hand today.

04 — Assurance

Measured before it ships. Deployed where the data already is.

We are not biosecurity scientists, pharmacovigilance assessors or export-control officers. That is why every rule pack is built with the people who are, and scored against their own labelled decisions.

Evaluation

The release gate

Every rule pack is scored against an expert-labelled set built from your own past decisions. No version ships until it clears:

  • Agreement with expert consensus, at a threshold agreed in writing
  • Full recall on critical criteria across the labelled set
  • Determinism verified across re-runs
  • Fails closed — uncertainty escalates, it never clears
  • Validation documentation generated by the release

Recall is set first, and agreed in writing. The time saving is whatever remains once it is met.

Deployment

Inside your tenant

Rule packs arrive as signed, versioned bundles — the pattern any licensed enterprise software uses.

  • Your documents never leave your environment
  • Versions change when you accept them, and each assessment records which ran
  • Signed offline packages where nothing outbound is permitted
  • Works best where Azure or M365 is already in place

Connector work and validation support are scoped and priced separately, agreed before work begins.

Why this holds

Model releases commoditise intelligence, not evidence.

None of them can tell you which rulebook version applied, or be signed for by a named person.

Start here

Four weeks, on your own documents

Inside your environment. Measured baseline numbers, a working prototype, success criteria agreed in writing first.

Book a call

Or write to hello@hridhaan.ai.