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Shayne Gad

Ph.D., D.A.B.T., A.T.S. ·

Cary, North Carolina
toxicology
statistical consultant
research and development
chemical
consumer product
contract testing
biotechnology
medical device
pharmaceutical
occupational toxicology
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industrial toxicology
development programs
preclinical
clinical
study design
study conduct
study reporting
evaluating clinical and product safety data
training and managing staff
dealing with U.S. and foreign regulatory bodies
commercial concerns
contract research organizations
labeling
FDA compliance issues for drugs
devices
dietary supplements
identifying new technology
developing new technology
putting new technology into use
writing reports
position papers
Material Safety Data Sheets
MAA/PLA/IND/NDA/PNA toxicology summaries
pharmacokinetic summaries
package inserts
preparing INDs
NADAs
DMFs
IDEs
510(k)s
preparing labels and package inserts for drugs
consumer products
presentations to FDA
designing experiments
designing surveys
executing surveys
pharmacokinetic analysis
statistical analysis
experimental data analysis
clinical data analysis
risk assessment
Proposition 65 assessments
Proposition 65 labeling
registration of OTC products
registration of dietary supplement products
registration of nutraceutical products
registration of sterilant products
litigation support
production of biologic products
development of biologic products

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