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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. 

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.
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