Study Design & Monitoring

Developing study data on the effects of chemicals in humans and the environment is an important component to the registration and approval of products. Ensuring that the development and evaluation of study protocols are done within proper U.S. guidelines is also of critical importance. TSG’s staff has extensive experience in all phases of laboratory and field regulatory studies, and offers a full range of capabilities in the application of these guidelines. Our consultants work with companies to determine the desired label use recommendations, and then design a comprehensive study program that supports achievement of that goal.

TSG is a leader in the practical application of
Good Laboratory Practices (GLP) to regulatory studies, conducting independent study audits and provides training in GLP compliance on an industry-wide basis. Our staff has direct experience in GLP, from both industrial and regulatory backgrounds, which is an integral part of every field study we design and manage.

TSG’s consultants coordinate all aspects of regulatory studies, from design and protocol development to implementation and reporting. With a deep understanding of how the conduct and presentation of a study affects its interpretation, our scientific team implements, monitors, prepares and reviews study reports to ensure registration. 

By properly setting study priorities and schedules, we ensure effective oversight and timely study completion. Our consultants guide a study throughout all phases, reviewing findings and producing quality results acceptable to regulatory agencies in the U.S. and abroad.