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.
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.
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.
