A good audit is far more than a simple catalogue of gaps – more important is crafting recommendations for a business that fit their needs, with realistic solutions and long-term guidance:

“John truly shares his expertise and knowledge with you.  During an audit we conducted together last year, he regularly gave the client practical and unbiased recommendations, making sure the focus was always on their ability to succeed, not just comply.”

– Jackie Cassada, President, Nottingham, England

Our mock FDA and PAI audit service is designed to give you a holistic view of your organization’s strengths and your weaknesses.  Many clients have used our expertise to conduct mock FDA inspections of their critical suppliers, especially CMOs and CROs, and then take the process we use and adopt it as their own due diligence for the future – doubling their return-on-investment.

For more audit and inspection help, check out these resources:

  • Preparing for an FDA Inspection from the PDA Letter
  • Checklist:  Managing the Inspection
  • Recorded Seminar & Resource Kit:  Bulletproof Yourself against FDA Enforcement

Review our mock FDA inspection service.

Contact us to turn compliance into a competitive edge