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. The practice is primarily focused on technical and regulatory support of new product development and the technical support of existing products. 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 33 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 and the recipient of the 2008 ACT Lifetime Achievement Award, Dr. Gad has authored or edited 39 books, 50 independent chapters and more than 300 papers and abstracts in the above fields. He has contributed to and has meaningful personal experience with IND (90 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, and Leadscope licenses and capabilities and has successfully qualified impurity, intermediates, residual solvent, and excipient levels in existing drugs for many of its clients.

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.