Placing and Monitoring Studies for Chemicals
To register chemicals for their intended use (antimicrobials, pesticides, pharmaceuticals, food additives, etc.), regulatory bodies require specific studies. These may include studies investigating efficacy, toxicology, toxicokinetics, animal safety, environmental fate, ecotoxicology, metabolism, exposure, and physical, analytical, and residue chemistry. These studies are used to determine a chemical’s use patterns, label claims, hazards, and exposure potential and to assess risks to human health and the environment. Studies may range from short-term experiments to complex, higher-tiered studies. It is critical that all studies are strategically designed and provide robust results to accurately categorize risk in support of product registration.
Exponent’s consultants can help clients place studies with contract research organizations (CROs) and monitor their progress from study design to analysis of results. Exponent offers expertise in an array of scientific disciplines to provide exceptional support in critical areas for the registration of chemicals. These include, but are not limited to, microbiology, toxicology, chemistry (analytical, metabolic, residue), ecotoxicology, environmental fate, health sciences, and statistics. Our team has in-depth knowledge of and established working relationships with CROs globally. Our consultants are experts in the studies required to meet global regulatory data requirements, as well as higher-tiered studies including ecological field studies (e.g., bee studies), environmental modeling (e.g., water monitoring), toxicology (e.g., mechanistic studies, evaluating the potential for endocrine interaction, mode of action, and human relevance), and market basket surveys. The strategically designed studies we oversee are conducted to the highest scientific standards and adhere to global guideline requirements, while keeping in mind cost effectiveness and critical deadlines. Our consultants’ knowledge of global testing guidelines, regulatory requirements, and Good Laboratory Practice (GLP) standards is invaluable in designing and generating studies for regulatory submissions and provides added value when placing and monitoring studies.