Skip to content

Expert Regulatory Services

Guiding Your Product to Success

KGK Science offers the largest breadth of regulatory support services in the nutraceutical, cannabis and hemp industries. Led by a former FDA regulator, KGK’s team of seasoned regulatory experts are uniquely equipped to provide an insider’s perspective into regulatory operations and the most effective way to reduce regulatory risk through verifiable evidence.

Claim Substantiation & Review

  • Substantiation Files
  • Letters of Support for Old Dietary Ingredient (ODI) Status
  • Letters to Support Substantiation of Claims Made on Labels or in Labeling
  • Letters of Toxicology Support for Dietary Ingredients Used at a Specific Serving Level
  • Label and Claims Review
  • Novel Foods

Product Licensing

Serious Adverse Event Reporting

Safety & Risk Assessments

  • New Dietary Ingredient Notifications (NDI)
  • GRAS Conclusions
  • Toxicology Risk Assessments of Ingredients or Ingredient Constituents

Regulatory Consulting

  • Citizen Petitions
  • Path-to-Market Strategies

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

  • 350

    Clinical Trials Across 40+ Indications

  • 150

    Publications

  • 10M

    Data Points Collected

  • 23

    Years In Business

  • 85

    Full Time Employees

  • 25,000

    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.
  • Area of Interest * Required
  • Consent