Any non-clinical laboratory facility you use to conduct safety and toxicology testing in animals may be subject to inspection by FDA, EPA, or other regulatory bodies. Polaris can prepare you by performing independent audits of sponsor or contract facilities and studies, giving you additional assurance that a lab is in compliance with regulations (e.g., 21 CFR 58) and SOPs. Should deficiencies be identified, Polaris auditors can recommend remedial actions.
Why wait for an FDA inspection to find compliance issues or deficiencies in your pre-clinical practices? By contacting Polaris today, you can ensure that you have properly implemented the Good Lab Practices procedures for which the FDA investigators will be looking.
We conduct compliance audits and save time to market for our customers worldwide. How can we help you?
Polaris Compliance Consultants, Inc. 1151 Executive Circle Suite 202
Cary, NC 27511-4589 (919) 463-0003