GMP (Good Manufacturing Practice) audits help ensure that products are manufactured via the Quality standards stipulated by the FDA and other health authorities.  Whether your products are manufactured in the US or elsewhere, as the sponsor you are responsible for the quality and safety of your products. Our global team of auditors can conduct GMP audits, including pre-engagement qualification and routine surveillance audits, of:

  • CMOs: 
    • API/drug substance
    • Drug product
    • Device manufacturers
  • Packaging/labeling contractors
  • Analytical laboratories
  • Warehouses
  • Distribution centers
  • Internal facility audit to help prepare your company or contractor for FDA and EU inspections by:
    • Conducting a mock audit
    • PAI (Pre-Approval Inspection)
  • Due diligence audits including venture capital due diligence audits

We can assist with post-audit remediation, if requested. We can assist in setting up CAPA programs and resolving associated issues, or can review CAPA plans and timelines.

In addition to audits and consulting, we can provide customized on-site training. Click here to learn more.