QAI provides long-term or temporary support to established Quality Assurance Units. QAI can operate as part of the existing QAU for one or more of the following audits and inspections:

  • Prequalification and requalification audits of CROs
  • Protocol evaluations
  • In-phase inspections of laboratory and field studies
  • Study raw data and final report audits

Expertise includes inspections and audits of:

  • Toxicological studies, including acute, sub-chronic, chronic, teratology, multi-generational, as well as ADME, and TK studies
  • Bio Analytical
  • Environmental fate studies, including degradation and metabolism, as well as field dissipation and ground water
  • Residue studies, including plant metabolism, magnitude of the residue, rotational and method validation
  • Recombinant DNA-pesticide and pharmaceutical studies, including characterization and expression of the protein in the GMO

Case Study