S22 / Assess

Retrospective audit.

Audit of a completed study before submission or inspection. Multi-lens read across applicable regulations.

4 min read

You'll leave with: Why M10 + M13A + ICH E6(R3) simultaneous-lens retrospective audits are uncommon — and what they catch.

/ Who this is for

The fit.

Sponsors pre-submission. Generic sponsors pre-ANDA. Indian CROs post-incident.

/ The work itself

What this delivers.

Retrospective audit report. Multi-lens audit (M10 + M13A + ICH E6(R3)). Submission-readiness scorecard, remediation priorities.

/ Why this matters

Where the edge is.

M10 + M13A + ICH E6(R3) simultaneous-lens audit — most operate single-lens. Cross-jurisdiction submission-readiness in one engagement.

/ 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 study and submission timeline.

Scoping.

Proposal aligned to audit lens count and depth.

Audit.

Document review, raw-data sampling, key-personnel interviews.

Report.

Submission-readiness scorecard, remediation priorities.

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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