Gad Consulting Services is an internationally recognized consulting practice serving primarily the pharmaceutical, medical device, and dietary supplement industries in the areas of preclinical and early clinical evaluation, safety assessment, statistics and risk assessment. Though the practice is primarily focused on technical and regulatory support of new product development, it is also very experienced and active in the areas of litigation support and occupational toxicology. The practice provides the full range of services in the areas of its expertise in an effective, flexible, reliable and timely manner.

Shayne C. Gad, Ph.D., DABT, ATS, the principal of the firm, has more than 30 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, inhalation toxicology, immunotoxicology, and genotoxicology. A past president of the American College of Toxicology and the Roundtable of Toxicology Consultants, Dr. Gad has published 33 books, 48 independent chapters and more than 300 papers and abstracts in the above fields. He has contributed to and has meaningful personal experience with IND (83 successfully filed to date), NDA, BLA, ANDA, 510(k), IDE, CTD, dietary supplement and PMA preparation. Dr. Gad is fully experienced with the design, conduct, analysis, and reporting of preclinical and clinical safety and pharmacokinetic studies for drugs, devices combination products and dietary supplements, and with regulatory submissions associated with them.

Gad Consulting Services holds SAS, DEREK, Meteor, and WinNonlin Licenses and capabilities.

Additional associated staff specializes in food and cosmetic safety and regulation, quality assurance, data management, analytical, environmental and information services support. Referrals are gladly provided for work outside our areas of expertise.