Clin Audits

Since 1994, ClinAudits, LLC, has established itself as a premier, independent, good practices (GXP) auditing and consulting firm assisting clients around the world comply with domestic and international regulations. ClinAudits’ senior auditors average more than 17 years of experience in assisting various clients through the compliance processes stipulated by the European Medicines Agency (EMEA), the United States Food and Drug Administration (FDA), the U.S. Drug Enforcement Agency (DEA), and similar regulatory authorities.

The Kinnelon, New Jersey, company also serves clients in the area of animal health. Under the tutelage of James Peters, ClinAudits assists animal health companies, as well as entities seeking to conduct studies of technologies intended for animal use, in understanding the relevant industry regulations. Dr. Peters, who earned his Bachelor’s degree from the University of Connecticut and his Master of Science and Doctor of Philosophy from Cornell University, spent 25 years in various research capacities at animal health pharmaceutical companies. Today, he brings his knowledge of drug discovery, technological innovations, and product development to ClinAudits and the firm’s clientele.

Clients evaluating leads or developing new products for livestock and companion animals benefit from ClinAudits’ multitude of services that span from evaluating safety and effectiveness from preclinical trials through to introduction to the marketplace. Not exclusively involved with animal health, ClinAudits has served more than 400 clients worldwide by evaluating Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Tissue Practice (GTP), and creating an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS).