Scientific & Technical Support: 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 the
proper Canadian 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 Canadian 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
Canada and abroad.
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| Key Contacts | |
 Saadia Eltayeb |
 Gary Burin |
 Beth Mileson |
 Greg Gorder |
TSG’s consultants are highly knowledgeable of the registration requirements for disinfectants regulated by both PMRA and TPD. TSG provides comprehensive product registration services, from determining data obligations and developing compliant labels, to compiling and submitting the registration application.
The goals of EPA's TSCA IUR program are to collect quality screening-level, exposure-related information on chemical substances in commerce in the United States and to make that information available for use by EPA and the public. The IUR data are used to support risk screening, assessment, priority setting and management activities at EPA and constitute the most comprehensive source of basic information on chemicals in commerce available to EPA.
TSG has offices throughout North America and Europe, including Sacramento, CA, Washington, DC, Canada, United Kingdom, Spain and Slovenia. Through these locations and our affiliates, TSG works with companies in 36 countries worldwide including China, Japan, Australia, New Zealand and Latin America.
REACH (Registration, Evaluation, Authorization and restriction of Chemicals) is an EU Regulation that came into effect on June 1st, 2007, imposing strict guidelines on the manufacture or import of chemicals, preparations and articles in or to the EU.
Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65, was approved by voters to address the growing concerns about exposure to toxic chemicals. Proposition 65 requires California to publish a list of chemicals, updated at least once a year, known to cause cancer, birth defects or other reproductive harm. Proposition 65 also requires California businesses to post notification about significant amounts of chemicals in the products they sell, in their homes or workplaces, or that are released into the environment.