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Strengthen your claims with science, strategy, and regulatory expertise.
Claims play an important role in communicating a product’s benefits, characteristics, quality, composition, or intended use. However, claims must be supported by appropriate scientific evidence and comply with the applicable regulatory requirements in the market where the product is sold.
Our team provides claims substantiation support to help companies understand applicable requirements, evaluate available evidence, and develop scientifically sound strategies for communicating product benefits and characteristics.
We work with you to:
- Strategically assess applicable regulations and claim requirements
- Review the scientific literature for existing supporting evidence
- Evaluate the strength, relevance, and quality of available scientific evidence
- Identify appropriate claim language and substantiation strategies
- Explore innovative pathways to support product positioning
- Design a clinical trial to generate evidence when additional research is needed
- Prepare scientific and regulatory documentation to support claims
- Support regulatory submissions in countries requiring pre-market approval or notification
- Manage claims substantiation projects from early product development through market launch
Health Claims
Health claims communicate a product's relationship to a health benefit, physiological effect, or other health-related outcome. Our experts can assess proposed health claims, evaluate the supporting scientific evidence, and develop a substantiation strategy aligned with applicable regulatory requirements.
Structure/Function Claims
Structure/function claims describe the role of a product, ingredient, nutrient, or other substance in supporting normal physiological structure or function. We can help evaluate proposed claims, assess the available scientific evidence, and determine an appropriate regulatory and substantiation approach.
Composition and Content Claims
Claims describing the composition, content, quality, characteristics, or other attributes of a product may be subject to specific regulatory requirements depending on the product category and market. Our team can assess proposed claims against applicable criteria and help ensure they are supported by appropriate product data and scientific evidence.
Other Product Claims
Depending on the product and market, companies may need substantiation for claims related to performance, efficacy, safety, quality, purity, tolerability, or other product characteristics. We can help identify applicable requirements and develop an evidence-based strategy to support appropriate claim language.
Learn how we can help you substantiate your claims and communicate product benefits with confidence.
