Ensure the quality, integrity, and reliability of your non-clinical laboratory studies with OECD Good Laboratory Practice compliance. QMICS helps pharmaceutical, chemical, and agrochemical organizations achieve and maintain GLP certification.
Good Laboratory Practice (GLP) principles govern non-clinical health and environmental safety studies submitted to regulatory authorities. We help test facilities implement robust GLP frameworks that satisfy OECD, FDA, and EPA requirements.
We evaluate your test facility's current practices against OECD GLP principles, covering study management, test system care, SOPs, data recording, archiving, and QA program effectiveness.
We develop comprehensive Standard Operating Procedures covering all GLP-required areas — from test substance characterization and equipment calibration to data management and archive access.
We help establish or strengthen your GLP Quality Assurance Unit (QAU), including inspection schedules, audit checklists, final study report reviews, and management reporting systems.
We prepare your facility and personnel for GLP inspections by national compliance monitoring authorities, conducting mock inspections and ensuring documentation is inspection-ready.
OECD GLP compliance means your non-clinical study data is accepted by regulatory authorities across all OECD member countries, eliminating the need to repeat studies for different markets.
GLP principles ensure raw data is accurately recorded, properly archived, and fully reconstructable — protecting your organization from regulatory rejection of study findings.
Systematic GLP compliance reduces the risk of study rejection, regulatory findings, and facility disqualification that can halt product development programs and cost millions.
GLP certification is a prerequisite for winning contracts from pharmaceutical, agrochemical, and industrial chemical companies seeking contract research organization (CRO) services.
A structured, proven approach delivering measurable compliance outcomes at every stage.
We review your test facility layout, equipment, personnel qualifications, and existing documentation systems to define the GLP compliance scope and identify critical gap areas.
We create a complete SOP framework covering all OECD GLP principles areas, with practical, facility-specific procedures your staff can implement effectively in daily operations.
We establish your Quality Assurance Unit structure, train QA personnel on inspection methodologies, and develop study and facility inspection programs that meet GLP requirements.
We provide on-site implementation support, conduct an internal GLP compliance audit across all study types conducted, and address findings before the regulatory authority inspection.
We prepare your facility for national GLP monitoring authority inspections, coach management and study personnel, and support you through the inspection process and response to findings.
Contact our experts today for a free consultation tailored to your organization.