New Dietary Ingredient Notifications
Expert Guidance Every Step of the Way
Dietary ingredients for use in dietary supplements can either be old, pre-DSHEA, grandfathered dietary ingredients (ODI) or New Dietary Ingredients depending on whether they were marketed and sold in interstate commerce prior to October 15, 1994. Our regulatory experts will determine whether your dietary ingredient is old or new.
NDI requirements are highly detailed, requiring an expert in NDI identity (chemistry) and safety (toxicology). Our team of regulatory experts, led by co-author of FDA’s NDI draft guidance for New Dietary Ingredient Notification and former FDA Branch Chief for Dietary Supplement Regulation Implementation, will provide you with a customized, all-in-one solution for successfully meeting NDI compliance.
- Strategy for filing an NDI notification
- Technical review of identity specifications and GAP analysis of toxicology data
- Recommendation for any pre-clinical safety studies (animal toxicology)
- Direct correspondence with FDA throughout the process and facilitation of a Pre-Notification meeting to ensure a successful submission
- Writing a comprehensive NDI Notification to meet federal regulatory requirements.
- Organization of all identity and safety information
- Organization of raw data
- Full copies of all cited references
- Drafting of written narratives
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.
