Toxicology Study Solutions

Toxicology is the study of the adverse effects of substances on living organisms. It involves assessing the potential health risks associated with exposure to chemicals, drugs, or other substances. Toxicology studies are crucial in various industries, including pharmaceuticals, cosmetics, and food and beverages. 

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Regulatory Requirements

FDA (U.S. Food and Drug Administration)

Requires 89+ toxicology studies for pharmaceuticals and biologics (21 CFR 312)

Health Canada

Requires toxicology studies for pharmaceuticals and biologics (C.02.015)

EFSA

Guidelines for toxicology testing and assessment

ECHA (European Chemicals Agency)

Requires toxicology studies for chemical substances (REACH Regulation)

Our Toxicology Study Solutions

Need Help with Toxicology Studies?

Contact us to learn more about our toxicology study solutions and how we can support your safety and compliance needs. Our team of experts is ready to assist you in ensuring the safety of your products and compliance with regulatory requirements. 

With over 18 years of experience and a proven track record of helping more than 2,000 brands achieve regulatory approval, GRAS experts are here to provide the precise support you need. We guide you through every step of the testing process, helping you secure final approval and achieve your business growth goals. 

If you have any questions or need more information, please fill out the form below and submit. 

Frequently Asked Questions

Toxicology studies provide critical safety data for FDA GRAS compliance by evaluating the potential adverse effects of substances. These studies, including in vitro and in vivo testing, help demonstrate that an ingredient or additive is safe for its intended use, aligning with FDA’s rigorous safety standards. 

While not always mandatory, toxicology studies are often crucial for GRAS certification when existing safety data is insufficient. These studies provide robust evidence to support safety claims, helping businesses meet FDA requirements and align with food safety and quality assurance certification standards. 

Toxicology studies play a crucial role in food testing by identifying potential risks such as chemical toxicity, allergenicity, and long-term health effects. By evaluating these risks early, businesses can address safety concerns proactively, ensuring compliance with food safety audit requirements and protecting consumer health. 

Toxicology studies provide essential data for conducting risk assessments by evaluating the potential adverse effects of exposure to a substance. This data supports regulatory compliance and ensures that products meet food safety and quality assurance certification standards, reducing the likelihood of recalls or market delays. 

GRAS Experts offer comprehensive support for toxicology studies, including study design, testing, and data interpretation. Our expertise ensures compliance with regulatory guidelines from FDA, EFSA, and Health Canada, helping businesses meet GRAS ingredient safety standards and achieve market readiness. 

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