GRAS Conclusions
Safety Above All Else
The Federal Food, Drug and Cosmetic Act places high levels of scrutiny on compliance with safety regulations for food ingredients, as do internet savvy consumers looking for FDA awareness and approval. GRAS conclusions are safety reviews conducted by experts qualified by scientific training and experience. Your GRAS conclusion will be drafted by our experts and either independently reviewed (self-GRAS), reviewed and submitted to FDA (submitted GRAS notice), or formally petitioned to FDA (food additive petition).
Putting safety above all else is at the heart of KGK Science, with our mission to ensure that consumers have access to safe and effective products. Our team of regulatory reporting experts will provide an all-in-one customized solution for ensuring your ingredient meets all the GRAS requirements.
- Technical review and GAP analysis to ensure that evidence will meet requirements
- Plan and conduct studies to support identity and safety data requirements including protocol development, study management, and analysis of results
- In-house expertise in statistics and food toxicology to assemble data and literature into a comprehensive dossier to support the GRAS conclusion
- A panel of independent expert food scientists to review the GRAS conclusion and provide final sign-off letters.
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.
