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Substantiation Files for Ingredients / Products

Maximizing Value Through Efficacy Substantiation

Being able to prove and substantiate the efficacy of your product or ingredient is important for regulators, and your customers. A thoroughly produced substantiation file is a cost-effective way to complete your due diligence process and reduce regulatory risk, providing a foundation for successfully differentiating your product from others in the market.

  • Full literature assessments
  • Evidence evaluation
  • Dossiers summarizing evidence from literature and studies
  • Advice on maximizing the value of claims

Creating a Substantiation File

In addition to regulatory bodies, consumers are increasingly performing their own research into the validity of claims found on nutraceuticals. Being able to thoroughly support your claims for regulators and your downstream customers is essential for establishing market distinction and protecting your business against regulatory non-compliance and predatory lawsuits. KGK can help with substantiation by creating a comprehensive substantiation file, which documents the level of evidence for each claim made on an ingredient in a product.

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

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  • 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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