Dr. Gad has more than 46 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 53 books, 75 independent chapters, and more than 387 papers and abstracts in the above fields. He has contributed to and has meaningful personal experience with IND (139 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 continues to successfully provided computational analysis of PK/TK data and qualify impurities, intermediates, residual solvents, and excipient levels in existing and under development drugs for many of its clients, as well as leachables and extractables for device clients. GCS has established and current experience in CAPA safety assessments preparing F-value classifications, OEL determinations, and providing both GLP and GMP audits (nationally and internationally).
Additional associated staff specializes in food and cosmetic safety and regulation, quality assurance, data management, analytical, medical writing, environmental, and information services support. Referrals are gladly provided for work outside our areas of expertise.