Our toxicology study management service is provided by registered toxicologists with vast experience managing toxicology studies on food ingredients.
The Challenge
Toxicology studies are major financial investments for businesses, and efficient study management can be the difference between success and failure. Managing toxicology studies can be time- and resource-consuming, requiring experience, confidence, and attention to detail. Intertek can take this resource burden from you and give you the peace of mind that your studies are designed and reported appropriately for your needs.
The Intertek Advantage
Our experts are well-versed in navigating the various, complex, and ever-changing tiered approaches to toxicology testing across all major jurisdictions, including the European Union, the United Kingdom, the United States, and China. As part of our toxicology study management service, we will help you ensure you only conduct the studies needed for your jurisdiction(s) of choice, and, if multiple studies are required, that they are designed to minimize time and cost without jeopardizing the outcome of your program.
While Contract Research Organizations (CROs) and other study monitors may have general toxicology study experience, their experience often comes from a pharmaceuticals or chemicals background, both of which have subtle but important differences compared to safety assessments for food ingredients. Our extensive experience monitoring toxicology studies on numerous types of food ingredients and food improvement agents—including novel foods, food additives, food enzymes, and food flavourings—will bring maximum efficiency to conducting and reporting your study.
International testing guidelines are available for many toxicology studies, but they are not “one size fits all.” Moreover, with many optional or case-specific endpoints, these guidelines can be open to interpretation. Our expertise ensures the right studies are designed and conducted appropriately for your specific regulatory needs.
For example, in the case of repeated dose studies, appropriate dose selection is especially important—these doses are often used to define the daily amounts of the ingredient you will be authorized to use. Finding a dose high enough for a sufficient margin of safety, but not so high as to cause excessive toxicity, is a difficult balancing act without the relevant knowledge and experience. Our experts are well-accustomed to dealing with this issue.
Study monitoring throughout the testing phase is also crucial to ensure the study is conducted correctly and according to protocol. This is especially important for larger and more complex studies, which have lots of moving parts and high costs. Our understanding of experimental procedures helps ensure that scientific quality and integrity is maintained throughout your study.
Lastly, as the ”final report” is the only study component that regulatory agencies assess, experience with study interpretation and findings is critical. We specialize in reporting toxicology studies specifically conducted on food ingredients to ensure your study is reported appropriately for your requirements.
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