Quality Assurance Consultancy provides long-term or temporary support to established quality assurance units (QAUs).
We can operate as part of the existing QAU for one or more of the following audits and inspections:
- Prequalification and requalification audits of contract research organizations (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
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