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 applicable regulations. Frequently, quality assurance functions extend facility-wide and include vendors and subcontractors, 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

• QAU Development/Maintenance - Develop infrastructure necessary for compliant QAU

• Data/Report Auditing - Toxicology, Product & Residue Chemistry, Health & Environmental Effects data and reports
• Inspections – Compliance assessments, third party inspections, Gap analysis and/or subcontractor inspections
• Training – On site regulatory or guidance-specific training , targeted half-day training sessions
• SOP/Document Control - SOP generation or supplementations, document control practices