Audit · 5 days

Pre-FDA Mock Audit

5-day AI-augmented mock inspection with an evidence repository. We surface every gap before the FDA does, then ship a remediation roadmap your QA team can act on the day after we sign.

Price

From $500

scoped per document volume

SLA

5 days

kickoff in 5 business days

For

Pharma / Device / NHP

FDA inspection scheduled

What's Included

  • AI Evidence Repository

    Upload your SOPs, batch records, training records, deviation reports, audit trails. AI builds a searchable, indexed repository in 24h. Reusable for the actual inspection.

  • AI Gap Analysis

    AI cross-references your evidence against 21 CFR Part 211 (Drugs), Part 820 (Devices), or NHPR (Canada NHP). Surfaces gaps with regulation-text citations.

  • Senior Consultant Review

    A senior auditor (Sam Sammane or Nour Abochama) reviews the AI findings using QGI's decision-grade framework. Replayable, signable, defensible.

  • Gap Report (PDF)

    Prioritized list of every finding (Critical / Major / Minor), with the affected SOP/record, the regulation cited, and the recommended fix.

  • Remediation Roadmap

    90-day plan with owners, deadlines, and acceptance criteria. Built so your QA manager can run it without us in the room.

  • Inspection Readiness Brief

    A 1-page exec summary plus a 5-page tactical brief for the inspection week — what the inspector will likely focus on, who answers what.

5-Day Engagement Flow

  1. Day 1 Kickoff + secure document upload to AI evidence repo
  2. Day 2 AI ingestion + initial gap-scoring across 21 CFR clauses
  3. Day 3 Senior consultant review of AI findings + on-site / video walkthrough
  4. Day 4 Drafting of gap report, remediation roadmap, and inspection brief
  5. Day 5 Sign-off call + handoff of deliverables + Q&A with your QA team

Why It Costs Less

Traditional pre-FDA mock audits run $12,500–$20,000 because they bill by senior-consultant day. Our AI does the heavy ingestion + cross-referencing in hours, then a senior consultant reviews and signs the findings.

You get the same quality of finding (often deeper, because AI catches what humans skim) at a fraction of the price. Final scoping depends on the document volume — single-site low-volume engagements start at $500; multi-site multi-product engagements scale up but stay well below traditional consulting rates.

Reserve your mock audit

Tell us your inspection date and document volume. We'll scope and quote within 24 hours.

Reserve a Discovery Call →