(571) 447-5500

Randy White, Ph.D.

EAS Independent Consultant

Dr. White has BS (Animal Science) and MS (Animal Physiology) degrees from Brigham Young University and PhD (Animal Nutrition and Toxicology) degree from Oregon State University. He has been a Medical Device / Pharmaceutical professional for 35+ years, working in academic research, contract research organizations, and corporate research and regulatory toxicology roles.

Dr. White has substantial experience in medical device, biologics, combination products, and nutritional supplement preclinical research and product development. Specific areas of his expertise are Preclinical Strategy, including determination of safety assessment and testing programs compliant with regulatory guidelines such as ISO 10993, FDA, EU, etc., GLP Compliance, and Preclinical Operations, including study design, conduct, and monitoring, risk assessment, and animal model development.

Dr. White’s experience and expertise has culminated from 20 years of leading (Manager/Director/Sr. Director) preclinical toxicology/safety testing at contract laboratories (4 years Utah State University, 4 years Utah Biomedical Test Laboratory, and 13 years WuXi AppTec), 14 years leading (Manager / Director / Technical Director) preclinical testing and safety assessment and post-market product safety stewardship at Baxter Healthcare, and 4 years as President / Consultant for Preclintox Services, LLC. Dr. White has been a member (1990 – 2017) of the U.S. Technical Advisory Group for ISO/TC194: Biological evaluation of medical devices (ISO 10993) and has been coauthor of several ISO 10993 guidelines. Most recently, Dr. White has been focused on EU MDR biocompatibility gap assessments and remediation to include preparation of chemical characterization toxicological risk assessments.

Key competencies include medical device safety assessment, toxicology, risk assessment, biocompatibility testing, and regulatory and GLP compliance, as well as experience in safety assessment, preclinical research, and product development of biologics, combination products and nutritional supplements.

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