Claim Substantiation
We specialize in validating product claims for healthcare and pharmaceutical products, ensuring every statement is accurate and compliant. Our expert team leverages comprehensive regulatory knowledge and cutting-edge data to support your claim substantiation needs worldwide.
DISCOVER MOREUnderstanding Claim Integrity
Claims represent the content, benefits, and unique selling points of your healthcare products, and can appear in leaflets, media commercials, and more. Each claim plays a vital role in positioning your product in the market and must comply with regional regulatory guidelines.
Accurate claim validation depends on the type of evidence provided, such as clinical data, in-vitro studies, and thorough risk-benefit analyses. Ensuring that these claims are supported by robust documentation minimizes rejections from regulatory authorities due to gaps in critical literature or trial design.
Expertise in Label Claim Validation
DDReg’s team of labeling experts brings deep experience in verifying and substantiating product claims. Our specialists work hand-in-hand with legal teams and sponsor organizations, utilizing our in-house databases and comprehensive bibliographical sources to ensure that every label claim in pharma is thoroughly validated.
Through meticulous reviews and critical evaluations, our approach to product claims substantiation safeguards your market position. We ensure that every claim meets the necessary regulatory criteria, thereby maintaining the integrity and trustworthiness of your pharmaceutical claims.
Our Claim Substantiation Expertise
- Comprehensive review of claim documentation
- Critical evaluation of clinical data and in-vitro studies
- Risk-benefit analysis and evidence validation
- Compliance with global regulatory guidelines
- Utilization of in-house databases and bibliographical resources
- Collaboration with legal teams and sponsor organizations