Letters of Toxicology Support
Validating Safety and Reducing Risk
If you have an Old Dietary Ingredient (ODI), you may need a letter of support from a toxicologist to validate that changes in serving levels will not present a risk to safety.
KGK Science’s regulatory team, led by the author of the Draft New Dietary Ingredient Guidance and former Branch Chief of Toxicology at the FDA, will provide your team with all the supporting documentation required to validate the safety of your product or ingredient.
- A synthesis of pre-toxicology safety evidence
- A letter from an expert toxicologist summarizing the available toxicological data with conclusions and recommended conditions of use for the product/ingredient.
Regulatory Consulting Expertise
Led by a former FDA Regulator, KGK’s seasoned regulatory experts are uniquely equipped to provide an insider’s perspective into regulatory operations and the most effective way to navigate a timely and compliant path-to-market. Backed by a vast network of scientific, legal, and regulatory professionals, you’ll receive dedicated support throughout each step of the process.
Leading Clinical Research Since 1997
Clinical Trials Across 40+ Indications
Data Points Collected
Years In Business
Full Time Employees
Supporting Your Business with High-Quality Expertise
As a premium full-service contract research organization, KGK Science provides clinical trial research and regulatory services that meet the highest quality standards, customized to meet the needs of our clients. Contact us today and stake your claim.