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Consulting Services is in its nineteenth 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 420 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, Australia, Canada, Japan, Korea, the United Kingdom, France,
Italy, Hungary, Germany, Sweden, Austria, Switzerland, Netherlands, Poland, Israel,
Brazil, Argentina, Chile, Mexico, New Zealand, India, Japan, Korea, Slovenia, and Russia. Areas of technical expertise include 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 34 years experience in the field and regular ongoing interactions with FDA. 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. |
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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