Quality Assurance Services
The quality assurance unit (QAU) is responsible for monitoring regulated, non-clinical studies to assure operational management that the facilities, equipment, personnel, methods, procedures, records, and controls are in conformance with the applicable regulations of that study. Frequently, quality assurance functions extend to the whole-facility, facility vendors and subcontractors, as well as document control and management.
Quality Assurance Services provides the quality assurance functions required by domestic (US FDA and US EPA) as well as international regulatory agencies (OECD, MHLW, etc.) to support research and marketing applications, product approvals, and registrations.
Our services include:
Toxicology, Product Chemistry, Residue Chemistry, Health Effects and/or Environmental data and reports for submission to regulatory authorities as well as facility and/or vendor records review.
On-site training in domestic or international regulations or specific, half-day refresher sessions.
Compliance assessments, third party inspections and/or subcontractor inspections.
Management of presticice registration with the US EPA and in all 50 states.
SOP generation or supplementtation, document control practices.
Especially for Smaller Companies
If you are a small, start-up company looking to develop your own QAU or lack available staff to perform necessary facility or vendor inspections, please visit:
Especially for Large Companies
Perhaps you represent a larger more established company needing temporary quality assurance or regulatory support, compliance training or inspection preparation; consider reviewing. If so, please visit: