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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)

  • Required For Pharmaceuticals, Food Additives, Cosmetics
  • Toxicology studies are required for drug approvals, food additive safety, and general safety for cosmetics.

Health Canada

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

  • Required For Pharmaceuticals, Food Additives, Cosmetics
  • Toxicology studies are required for drug approvals, food additive safety, and some cosmetics.

EFSA

Guidelines for toxicology testing and assessment

  • Required For Food Additives, Food Contact Materials, Novel Foods
  • Toxicology studies are required for food additives, materials in contact with food, and novel foods.

ECHA (European Chemicals Agency)

Requires toxicology studies for chemical substances (REACH Regulation)

Our Toxicology Study Solutions

  • Study Design and Protocol Development: Expert guidance on designing and conducting toxicology studies
  • Toxicology Testing and Analysis: Conducting in vitro and in vivo toxicology studies
  • Data Interpretation and Reporting: Comprehensive analysis and reporting of toxicology study results
  • Regulatory Submission and Compliance: Support with regulatory submissions and compliance
  • Risk Assessment and Management: Expert guidance on risk assessment and management

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. 

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