Use cases

Five rule packs on one engine

The pipeline is the same in every case: read the documents, map them against a dated version of an external framework, cite the passage behind every finding, record the audit trail, route to a named reviewer. Only the rulebook changes.

RULE PACK 01 First to build

Dual-use and biosecurity screening

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

What it does

  • Ingests proposals, protocols and technical annexes in full — not only titles and abstracts, where the risk rarely sits
  • Assesses each against the applicable frameworks: US DURC and pathogen-with-pandemic-potential criteria, EU dual-use regulation, Australia Group lists
  • Flags the specific criterion touched, and links directly to the passage that triggered it
  • Assigns a confidence level and routes low-confidence items to human review automatically
  • Drafts the assessment memo the reviewer would otherwise write from scratch

Outcome

Coverage moves from a shortlist to the full portfolio, and every decision arrives with its own evidence attached.

Buyer

Head of research security, programme director, scientific director — at research funders, product development partnerships and private foundations.

RULE PACK 02 Largest long-term market

Export control and technology transfer

Screens technical content and intangible technology transfer against export control lists, and records which dated version of the list was applied.

What it does

  • Reads unstructured technical material — collaboration agreements, manuscripts, technical exchanges, transfer packages
  • Assesses against EU Regulation 2021/821 Annex I and the underlying international regime lists
  • Records the exact list version in force at the moment of screening, so the decision can be defended later
  • Flags intangible transfer risk — the least-tooled and highest-volume part of the regulation
  • Produces the classification record the compliance officer signs

Outcome

The compliance function can screen technical content, not only catalogued goods — and can prove what it screened against.

Buyer

Head of trade compliance, export control manager — in pharma, biotech and CDMOs. The budget line already exists.

RULE PACK 03 High volume

Pharmacovigilance case triage

Triages incoming 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 probable duplicates, with the evidence for each suggestion
  • Drafts the case narrative for review rather than replacing the reviewer
  • Writes back into the safety database with e-signature and full audit trail

Outcome

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

Buyer

Head of pharmacovigilance, drug safety operations lead — at mid-size sponsors and contract research organisations.

RULE PACK 04 Largest pharma market

Deviation and CAPA investigation

Assembles the evidence base for a quality investigation and drafts the reasoning, 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 candidate root causes with the evidence supporting and contradicting each
  • Drafts the investigation rationale in the organisation's own format
  • Writes back into the quality system under formal change control

Outcome

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

Buyer

QA director, head of quality — at pharmaceutical manufacturers and CDMOs.

RULE PACK 05 Held in reserve

Regulatory 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 the exact section and document version
  • Re-runs against a revised submission and reports what changed

Outcome

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

Buyer

Head of regulatory operations — at sponsors and regulatory affairs functions.

Start here

A fixed-scope assessment engagement, on your own documents

Four weeks. Your documents, your frameworks, inside your environment. It produces measured baseline numbers and a working prototype. Success criteria and the route to production are agreed in writing before it starts.

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