We work with our suppliers to ensure that high quality standards are in place for facilities, procedures and staff and that all work is conducted in accordance with the expectations of our customers. Our Quality Management Program has the following components.

ICH and GLP Compliance
Standard Operating Procedures
Animal Welfare
Maintenance of Records for Regulatory Purposes
Independent QA of Each Study

ICH and GLP Compliance.
We work with site personnel to ensure that the services performed are in compliance with all applicable laws and regulations, including compliance with International Conference on Harmonization (ICH) and Good Laboratory Practices (GLP), and that Sponsors and any responsible regulatory authorities will have access to any relevant records, programs and data as may be reasonably requested for purposes related to filing and prosecution of submissions to regulatory agencies. We meet this standard by providing regular training and conducting regulatory compliance audits.[back to top]

Standard Operating Procedures.
We work with site personnel to develop and maintain efficient and effective processes and standard operating procedures (SOPs) to be used in performance of the work, and to ensure that these meet customer requirements and comply with ICH and GLP guidelines. We require that all work be conducted in accordance with SOPs approved by the customer and we conduct routine study audits to monitor compliance.[back to top]

Animal welfare.
We require that any research conducted on vertebrate animals under one of our service agreements is compliant with the Animal Welfare Act [7 U.S.C. 2131 et seq.] and associated regulations from the Department of Agriculture [9 CFR, 1.1-4.11] pertaining to the humane care, handling and treatment of vertebrate animals held or used for research, teaching, or other activities. We monitor compliance through regular audits. [back to top]

Maintenance of Records for Regulatory Purposes.
We work with site personnel to ensure that they maintain all applicable records and data relating to the services during and after the term of the Agreement and in compliance with all applicable legal and regulatory requirements, including requirements of the U.S. Food and Drug Administration, the European Medicinal Evaluation Agency, and other regulatory agencies in Europe or other jurisdictions identified by customer. [back to top]

Independent QA of Each Study.
We perform an independent quality assurance review of each study. [back to top]