REGULATORY TOXICOLOGY
TSG combines a broad range of expertise to evaluate potential health and environmental risks. We provide a complete range of services in all aspects of toxicology including mammalian toxicology evaluations, human exposure analysis and human health risk assessments.
TSG's outstanding team of toxicologists are highly skilled in the four basic components of risk assessment — hazard identification, dose-response determination, exposure assessment and risk characterization — and fully conversant with applicable regulatory guidelines and procedures. We specialize in unique, custom-designed assessments employing alternative methodologies most suited to the proper resolution of specific problems.
Our staff of fully accredited toxicologists is highly skilled in the evaluation and interpretation of all toxicological studies, including acute, subchronic and chronic toxicity; developmental and reproductive toxicity; neurotoxicity and oncogenicity; transport, fate and disposition of chemicals in the environment; and potential chemical impact on animal species and ecosystems.
TSG's toxicology staff has many years of experience in the evaluation and interpretation of data from in vivo, in vitro, and mechanistic studies, employing a total-weight-of-evidence approach to develop an overall toxicological profile. While fully adhering to the appropriate evaluation criteria, TSG makes full use of newly emerging information from the scientific community and developing advances in evaluation and assessment methods.
Our consulting staff has outstanding experience in determining dose-response relationships from animal studies and in extrapolating such data to humans. TSG determines the most appropriate toxicological benchmarks to use in risk assessment. We use various models to develop cancer potency factors from oncogenicity data. In conducting dose-response assessment, TSG employs scientifically rigorous approaches and state-of-the-art methodologies. TSG staff is skilled in assessing human exposure. We are familiar with and typically use methodologies that are generally accepted by authoritative bodies such as the US EPA, US FDA, EU Scientific Committees and WHO.
TSG has extensive experience in all facets of human risk characterization. We continuously seek to develop and use new techniques that improve the level of confidence in the risk assessment and define and quantify uncertainty, including route-specific pharmacokinetic considerations, less-than-lifetime exposure and risk estimations and distribution-based approaches for exposure/risk analysis.
TSG staff includes internationally recognized experts in toxicology with years of experience in the design, interpretation and use of toxicity studies. We have consulted on matters concerning pharmaceuticals, pesticides, food additives, veterinary drugs, industrial chemicals and consumer products and have extensive experience in working with regulatory officials at the U.S.EPA and FDA, and with similar agencies in the European Union, Canada, California and other states.
Affiliates: