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.
Leading Clinical Research Since 1997
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350
Clinical Trials Across 40+ Indications
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150
Publications
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10M
Data Points Collected
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23
Years In Business
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85
Full Time Employees
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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.
As part of our multi-million-dollar research program, KGK has played an important role in helping us confirm the health benefits of our products, especially VitaFiber IMO. Their clinical trial research has contributed to our submission and product acceptance by the world’s top health regulatory agencies. They are a thoroughly professional organization with a strong understanding of businesses’ requirements.
We are so grateful to have been introduced to the professional team at KGK Science. They were patient with our inexperience, assisted us in building a reputable program, created education opportunities with top-notch experts in the field of Dietary Supplements and FDA regulations and guided our models to create truly imaginative studies that will contribute to the scientific body of knowledge in an honorable way.
KGK is responsive and adaptive to our needs, which is important to get a human clinical trial done with good design and within the time frame.
