Pre-Inspection Snapshot
A clear picture of where you stand — before anyone official asks.
A targeted inspection readiness assessment scoped to one site or study. We review your documentation, regulatory files, and operational processes against what a sponsor or FDA inspector would evaluate — then deliver a written findings report with prioritized corrective action recommendations.
Fixed scope. Fixed deliverable. No open-ended engagement.
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Document and regulatory file review (submitted electronically)
Written findings report with risk-tiered observations
Prioritized corrective action recommendations
45-minute debrief call
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Sites expecting a sponsor visit or audit within the next 60–90 days, or organizations that want an honest baseline before beginning a quality improvement program.
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Written report within 7 business days of document submission