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Our global regulatory group conducts GLP, GMP, GCP and Part 11 audits for a variety of regulated industries. We conduct due diligence audits, mock FDA inspections, vendor audits, contractor audits and internal audits covering areas including: production of chemical entities, sterile and non-sterile production, clinical investigations, laboratories and internal quality systems. In the course of our audits, our staff provides assistance with compliance and advice as to regulatory risk as well as finding non-compliant issues  |
