Gad Consulting Services is in its twenty-first year as a drug and medical device toxicology and regulatory consulting firm which offers services tailored to meet the needs of its clients in the areas of expertise of its principal and associates. We have successfully served the needs of more than 500 client firms in the fields of pharmaceutical development and regulation, and drug development, including direct experience with biotechnology, medical device development and registration, experimental design, clinical and biostatistics report writing, statistical analysis and risk assessment, dietary supplement evaluation and review, IND/IDE/CTA/CTD/510(k) preparation, biocompatibility, clinical data management, occupational toxicology, and training. Our clients include firms from the United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Poland, Russia, Slovenia, Sweden, Switzerland, and The United Kingdom.
Areas of technical expertise include: biocompatability testing, impurity qualification, neurotoxicology, inhalation toxicology, GMP manufacturing audits (US & international), immunotoxicology, animal models, combination products, predictive toxicology, and the current capabilities and availability of contract laboratory, production, and research organizations. Each and every project is considered and tended to individually and independently, but with the benefit of more than 37 years experience in the field and regular ongoing interactions with FDA and other regulatory agencies.
Quarterly trips are made to China for GLP and GMP inspections and for meetings with the CFDA.
We maintain a current library of inter-regulatory regulations for drugs, devices, and pesticides. This includes FDA Guidances (CDER, CBER, CDRH), ICH, ISO (10993), EMEA, FIFRA testing, OECD testing, FAO requirements, and TSCA testing.
Shayne Cox Gad, Ph.D., D.A.B.T.
102 Woodtrail Lane
Cary, North Carolina 27518
Phone: (919) 233-2926
Fax: (919) 233-2927