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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. 

Expert Regulatory Services

Leading Clinical Research Since 1997

  • 400

    Clinical Trials in 40+ Indications

  • 150+


  • 4000+

    Regulatory Projects Completed

  • 27

    Years In Business

  • 45,000

    Participant Database

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.

Request a 3-Day Quote

Interested in learning more about how KGK Science can help move your product to market with confidence? Simply fill in the form below and someone will be in touch with you within 24 business hours.
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