S06 / Assess

Gap analysis.

Diagnostic audit identifying specific gaps between current state and a regulatory benchmark — ICH M10, ICH E6(R3), QMSR, ICH M13A, EU MDR Article 117, or similar inflection.

5 min read

You'll leave with: What a structured gap analysis surfaces that an internal team can't, and how the deliverable should be scoped.

/ Who this is for

The fit.

Any organisation facing a regulatory inflection. Pre-implementation gap-finding. Pre-inspection reality-check. Pre-audit dry-run.

/ The work itself

What this delivers.

Gap analysis report with specific findings, remediation priorities, compliance roadmap. Available structured per-inflection (M10, E6R3, QMSR, M13A, Article 117) or as extended scope.

/ Why this matters

Where the edge is.

Structured per-inflection — M10 gap and QMSR gap are not the same exercise. Universal entry point: most engagements start here. Faster turnaround than firm-style engagements where the diagnostic gets buried in deliverable theatre.

/ How engagement runs

The shape of the work.

Every engagement is scoped per situation. The shape — focused diagnostic, structured implementation, ongoing partnership — emerges from the discovery conversation rather than a fixed package. Some engagements are short and intense; some are months-long structural builds; some are recurring quality oversight. We talk first, then scope.

Discovery.

Confirm regulatory benchmark and audit scope.

Scoping.

Proposal aligned to inflection (tight-scope diagnostic vs extended-scope assessment).

Diagnostic.

Document review, interviews, on-site if needed.

Report.

Gap report, prioritised remediation roadmap, often leading to remediation engagement.

What to do next.

If this is the work in front of you, the next step is a conversation. I read every message and respond personally. No contact forms. No sales sequence. Just a discovery conversation to understand whether the fit is real, and what the shape of the work would be.

Cadence promise: I publish weekly on regulated AI governance. If a week is missed, the journal entry explaining why goes up in real-time.

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