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
Use cases

Five rule packs on one engine

The pipeline is the same every time: read, map to a dated framework version, cite the passage, record the trail, route to a named reviewer. Only the rulebook changes.

Where this stands today. Rule pack 01 is available and runs end to end. Pack 02 is in development; packs 03 to 05 are planned — described here as designed, not delivered.
RULE PACK 01

Biosecurity Screening

Screens research proposals for content that could create biosecurity or dual-use risk, before funding is committed.

What it does

  • Reads proposals, protocols and annexes in full — not titles and abstracts, where the risk rarely sits
  • Assesses against US DURC and pandemic-potential criteria, EU dual-use regulation and Australia Group lists
  • Flags the criterion touched and links to the passage that triggered it
  • Routes low-confidence items to human review, and drafts the reviewer's memo

Outcome

Coverage moves from a shortlist to the full portfolio, every decision carrying its own evidence.

RULE PACK 02

Export Control

Screens technical content and intangible transfer against export control lists, recording which dated list version applied.

What it does

  • Reads collaboration agreements, manuscripts, technical exchanges and transfer packages
  • Assesses against EU 2021/821 Annex I and the underlying regime lists
  • Records the list version in force at screening, so the decision can be defended later
  • Flags intangible transfer — the least-tooled, highest-volume part of the regulation

Outcome

Compliance can screen technical content, not only catalogued goods — and prove what against.

RULE PACK 03

Pharmacovigilance Triage

Triages adverse event cases and drafts the narrative, inside a validated environment that writes back under change control.

What it does

  • Ingests case intake from the safety database and source documents
  • Assesses seriousness and expectedness against the reference safety information
  • Suggests coding and detects duplicates, with the evidence for each
  • Drafts the narrative for review, and writes back with e-signature and audit trail

Outcome

Handling time per case falls against a number the organisation already measures and reports.

RULE PACK 04

Quality Investigations

Assembles the evidence base for a quality investigation, on top of the existing quality system rather than in place of it.

What it does

  • Pulls batch records, prior deviations, related CAPAs and relevant SOP sections
  • Surfaces precedent — comparable events, what was concluded, what was implemented
  • Proposes root causes with the evidence for and against each
  • Drafts the rationale in your own format, and writes back under change control

Outcome

Investigations close faster, and the reasoning remains reconstructable at inspection years later.

RULE PACK 05

Submission Consistency

Checks a submission for internal contradiction across modules before it goes to the agency.

What it does

  • Reads across submission modules and supporting documents as one corpus
  • Detects contradictions in figures, claims, dates and cross-references
  • Traces every finding to section and document version
  • Re-runs against a revision and reports what changed

Outcome

Avoidable deficiency letters are caught internally, where they cost days rather than months.

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A fixed-scope assessment engagement, on your own documents

Four weeks on your documents, inside your environment. Measured baseline numbers and a working prototype. Success criteria agreed in writing before it starts.

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