Gad Consulting Services is in its sixteenth 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 370 client firms in the fields of pharmaceutical development and regulation, drug development, 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, Australia, Canada, Japan, Korea, the United Kingdom, France, Italy, Hungary, Germany, Sweden, Austria, Switzerland, Poland, Israel, Brazil, Argentina, Chile, New Zealand, India, Japan, Korea and Slovenia.

Areas of technical expertise include neurotoxicology, inhalation toxicology, 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 30 years experience in the field and regular ongoing interactions with FDA.

We maintain a current library of inter-regulatory regulations for Foods, Drugs, and Devices. This includes FDA Guidances (CDER, CBER, CDRH), ICH, ISO (10993), EMEA, FIFRA testing, OECD testing, and TSCA testing.



(Impurities, Leachables,
Degradants, Extractables,
Excipients, etc. Evaluation)

(Public Utility)


Gad Consulting Services
Shayne Cox Gad, Ph.D., D.A.B.T., ATS
102 Woodtrail Lane
Cary, North Carolina 27518
Phone: (919) 233-2926
Fax: (919) 233-2927
scgad@gadconsulting.com

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