Regulatory Compliance and Product Safety

Trusted Experts Guiding Clients to Improve their Environments

Whether our focus is helping our clients maintain compliance or verifying the safety of a product, our goal is always to help provide peace of mind for you and consumers. The health science experts at CTEH support client regulatory needs for food, drug, and consumer products, and recommend testing and evaluation strategies for new or existing products.

Our team is capable of:

• Consulting on toxicity testing strategies for existing or new products
• Monitoring regulatory activities that might affect our clients’ products and services to support regulatory decisions with sound science
• Interpreting and summarizing results of toxicology, genotoxicity, and carcinogenicity studies and providing expert scientific opinions
• Performing health risk assessments for consumer products
• Performing health hazard assessments for nanotechnology-based products and materials
• Preparing regulatory submissions and serving as regulatory liaison
• Reviewing scientific journal publications and evaluating federal scientific and technical reports, as well as state and local government documents for scientific merit
• Support to counsel as subject matter experts

Prop 65 Compliance Services

The Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65 (Prop 65) requires any businesses wanting to operate in California to provide warnings regarding potential exposures to chemicals or substances that cause cancer, birth defects, or reproductive harm in humans. The impact of the regulation has grown to affect a wide variety of industries with nearly 1,000 substances listed for consideration. Importantly, safe harbor levels dictate the level of exposure to a listed chemical below which does not require a Prop 65 warning. CTEH toxicologists and health scientists can:

• Conduct critical reviews of supply chains, product formulations, and manufacturing processes; 
• Design analytical testing strategies; 
• Conduct exposure assessments and risk characterization;
• Advise on product formulation;
• Perform Safe Harbor level review per OEHHA guidelines; and,
• Design, perform, and/or report on exposure simulation studies.