Label & Claim Reviews
Your Claims Backed by Science
Depending on the market you’re selling into, failure to comply with labeling and claim requirements can result in misbranded labels or products considered unapproved foods or unapproved new drugs. Misbranded labels and or ones with inappropriate claims result in embarrassing enforcement actions made public by regulatory authorities or costly import detentions. Products may even be added to a country’s import bulletin or alert system, and company information subsequently shared with food authorities from foreign governments, resulting in further barriers to international trade.
- Label review for violations of federal regulatory compliance requirements
- Thorough label reviews for misbranding (based on desired regulatory market)
- Review of all claims made on the label (and in labeling, if desired)
- Regulatory consulting for labeling best practices, developing new labels, improving compliance, and for entry into new markets
Upon reviewing your label thoroughly through the lens of a regulatory expert, KGK Science can help you ensure that your product makes it to retailers and customers and not the hands of federal regulators.
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.
