Quality Assurance Consultancy provides unmatched support for quality assurance units (QAUs) monitoring Good Laboratory Practice (GLP) Studies.
Our specialists can operate as part of your existing QAU (full or part time) or as an independently contracted QAU. Whether you need a long- or short-term solution, we can meet your requirements and can support your teams when:
- Conducting prequalification and requalification audits of contract research organizations and vendors
- Conducting internal facility inspections
- Conducting protocol, in-phase, data, and report audits
- Report findings from audits/inspections to the study director and management
- Preparing periodic reports to study directors and management
- Preparing and signing the QA statement in the final report,
- Preparing and maintaining the QAU SOPs
- Maintaining a copy of the master schedule, study protocols, and study specific QAU files
- Conducting initial and on-going GLP training
Additionally, we offer outsourcing solutions that support facilities that are too small or too new to justify a full-time QAU: industry task forces that require an external, independent QAU: university laboratories that prefer to outsource the QAU function, and more. Our core practice includes expertise in the following areas:
- Product chemistry
- Bioanalytical chemistry
- Toxicological studies, including acute thru chronic, inhalation, genetic, ocular, developmental and reproductive, in vivo and in vitro metabolism and pharmacokinetics
- Environmental fate studies, including aerobic and anaerobic degradation, soil/sludgeadsorption/desorption studies
- Field studies including soil dissipation, ground water, plant and animal residues, worker exposure, and storage stability
- Endocrine disruptor studies
- Anti-microbial studies
- Entomology studies
