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 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 (CROs) and vendors
- Conducting internal facility inspections
- Conducting regulatory inspections
- Conducting protocol in-phase, data and report audits
- Reporting the findings from audits and inspections to the study director and management personnel
- Preparing periodic reports to study directors and management personnel
- Signing the quality assurance (QA) statement in the final report
- Maintaining the QAU standard operating procedure (SOP)
- Maintaining a copy of the master schedule, study protocols and QAU file for GLP studies
- 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 method validation and chemistry
- Toxicological studies, including acute, sub-chronic, inhalation, genetic, ocular, developmental and reproductive, in vivo and in vitro metabolism and pharmacokinetics studies
- Environmental fate studies, including aerobic and anaerobic degradation, soil/sludge adsorption/desorption studies
- Residue studies including soil dissipation, plant and animal residues, worker exposure and storage stability studies
- Endocrine disruptor studies
- Anti-microbial and vaccine safety and toxicity studies–including those for the SARS-coV-2 virus
