Guide · 2026-09-24

How to Choose a GLP Consultant: 9 Questions Before You Sign

A bad GLP consultant wastes your money; a good one pays for itself at the first inspection. Nine questions separate them.

  1. Who exactly will do the work? Names and CVs of the auditors, not the sales contact. GLP auditing is a craft; juniors supervised loosely is a risk.
  2. What is in scope, precisely? Facility audit, study audit, data audit, report audit — each is a different engagement. Get the checklist or agenda.
  3. What does the deliverable look like? Ask for a sample (redacted) findings report. Vague reports produce vague remediation.
  4. How do you stay independent? If the same firm audits and then sells the remediation, findings get soft. Separation matters.
  5. What are your credentials? Years of GLP auditing, relevant registrations (e.g. RQAP-GLP), and references from labs like yours — call the references.
  6. Which regime do you audit to? FDA 21 CFR Part 58, OECD GLP, EPA GLP — confirm they audit yours, not a generic “GxP” checklist.
  7. What is the fee structure? Day rate or fixed fee, what's included, travel and expenses, and what breaks the fee (extra days, re-audits).
  8. What is the timeline? When can they start, how long on site, when does the report land. Inspection dates don't move for slow reports.
  9. What happens after findings? Is remediation support included, or is that a second engagement? Who verifies the CAPA closed?

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