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.
Screens research proposals and development documents for content that could create biosecurity or dual-use risk, before funding is committed.
Coverage moves from a shortlist to the full portfolio, and every decision arrives with its own evidence attached.
Head of research security, programme director, scientific director — at research funders, product development partnerships and private foundations.
Screens technical content and intangible technology transfer against export control lists, and records which dated version of the list was applied.
The compliance function can screen technical content, not only catalogued goods — and can prove what it screened against.
Head of trade compliance, export control manager — in pharma, biotech and CDMOs. The budget line already exists.
Triages incoming adverse event cases and drafts the narrative, inside a validated environment that writes back under change control.
Handling time per case falls against a number the organisation already measures and reports.
Head of pharmacovigilance, drug safety operations lead — at mid-size sponsors and contract research organisations.
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.
Investigations close faster, and the reasoning remains reconstructable at inspection years later.
QA director, head of quality — at pharmaceutical manufacturers and CDMOs.
Checks a submission for internal contradiction across modules before it goes to the agency.
Avoidable deficiency letters are caught internally, where they cost days rather than months.
Head of regulatory operations — at sponsors and regulatory affairs functions.
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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