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Inspection Readiness MOT
A structured mock inspection, honest gap analysis, and a prioritised action plan — delivered in 2 to 3 weeks. Fixed scope. Clear output. No surprises on the day.
The problem
Inspections expose what internal processes miss. If your only rehearsal is the real thing, the findings become public record.
The team knows the Code in theory. But replicating the pace, pressure, and document requests of an actual inspection is something entirely different — and no one has done it.
The findings sit in a spreadsheet. Ownership is unclear. Priority has drifted. The inspection date is now three weeks away and the same issues are still open.
When a case breaks publicly, boards ask questions fast. Without a structured readiness view, you have no credible answer — only reassurances that don't hold up to scrutiny.
Institutional memory of what was reviewed, what was challenged, and what passed is gone. Your current team is starting from scratch, with no record of what worked before.
What's included
The engagement is deliberately fixed in scope so it can be completed before your inspection window closes — without disrupting your team's ongoing workload.
Review of your end-to-end approval workflow — from brief to sign-off. Signatory involvement, version control, SOP currency, and whether the process on paper matches the process in practice.
Verification that Final Signatory qualifications are current, properly documented, and that sign-off records are retrievable in the format an inspector would expect.
Assessment of whether training is completed, recorded, and evidenced for all staff with Code-relevant responsibilities — including induction records and annual refresher completion rates.
Review of how AE reports received through promotional or medical activities are captured, triaged, and passed to PV — and whether staff understand their reporting obligations.
Assessment of how your organisation classifies materials — and whether those classifications are consistently applied and documented across medical affairs, marketing, and digital channels.
Review of your digital content approval process, social media policy, third-party content oversight, and how off-label risk is managed across owned and earned channels.
Assessment of how speaker payments, advisory board fees, and hospitality are recorded, approved, and retrievable — including the completeness of transfer of value documentation.
Review of whether annual declarations are completed, stored, and linked to the relevant staff roles — and whether the declaration process is auditable in the way an inspection demands.
What clients say
The mock inspection was genuinely uncomfortable — which was exactly the point. Anzal found six areas the internal audit had missed. We fixed all of them before the real inspection. The outcome was clean.
The gap report was specific enough to action immediately. Not a generic checklist — actual findings with named process owners and recommended fixes. We tracked it like a project and were ready in five weeks.
Who it's for
Inspection date confirmed or anticipated within the next quarter — needs a structured readiness view before it arrives.
Internal audit has run, gaps are known, but an independent external view is needed to validate scope and urgency.
A case ruling or industry news has prompted board-level questions — and you need a credible, evidence-based answer within weeks, not months.
Recently appointed into a compliance, regulatory, or medical affairs role and need a baseline view of where the business actually stands.
Key compliance personnel have left and institutional knowledge of what passed last time — and why — has not been documented or transferred.
Launching in a new indication, starting digital programmes, or entering HCP engagement activities where compliance requirements are unfamiliar.
Frequently asked questions
Typically 2 to 3 weeks from kick-off to final report delivery. The timeline is structured so that the gap analysis and prioritised action plan are in your hands with enough time to address findings before the inspection window. Where the timeline is tighter, this is discussed on the discovery call.
A structured review of your materials approval process, training records, signatory documentation, and governance framework — conducted as if it were a real inspection. This includes document requests, process walkthroughs, and targeted questions designed to replicate the approach an ABPI or MHRA inspector would take.
Yes — the engagement is collaborative. Your team participates in the mock inspection so they understand what to expect on the day, not just what the findings were. The aim is to leave your team better prepared, not just to produce a report.
Fixed-scope pricing, discussed on the discovery call. There is no open-ended retainer required — this is a defined engagement with a defined output. The scope can be adjusted for smaller affiliates or focused reviews of specific areas.
Book a discovery call to discuss your timeline, current state, and what the engagement would cover. No commitment required at this stage.
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