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
