Regulatory Science & Product Development Experts helping customers
Commercialise Products | Reduce Time to Market | Achieve Compliance | Grow Business
Claims of a particular food product demonstrates product efficacy, safety and superiority, thereby, distinguishing its positioning advantage in terms of its uniqueness or with reference a competitor product. A special food claim in particular should be supported with substantiation, be specific and should provide distinction with reference to it being a therapeutic or special food claim, since this can affect its categorization as a medicine or a food product. Also, unsubstantiated and misleading claims may lead to regulatory disciplinary action which could even include product recalls and or suspension of market authorisation.
Vyomus Consulting provides end-to-end claims support services, ensuring that a claim is substantiated with appropriate scientific literature and product efficacy testing data, clinical study consultation for product claims substantiation and scientific support through literature reviews for certain claims substantiation.
With its extensive experience and well recognized expertise, Vyomus guides customers to select appropriate claims based on technical, scientific, and regulatory science insights which will ensure the products are compliant to current regulatory requirements.
We provide “intelligent strategies“ instead of simplified, often cost-intensive routine product Development Programs to ensure the highest possible regulatory acceptance of your product. We thereby ensure effective compliance and thus help you, our customers navigate the complex regulatory landscape and make right decisions. Hence, emerging and established firms trust Vyomus Consulting as their partner to deliver customized strategic guidance and creative “hands-on” solutions to categorize and register their products efficiently.
Our senior practitioners have a unique blend of business, science, regulations and technology expertise and include experts in product development, regulatory affairs, pharmacology, toxicology, preclinical and clinical trial design and evaluation, biostatistics, each with extensive product commercialisation experience.
Regulatory Consulting, Regulatory Strategy, Preclinical Study Approvals, Clinical Study Approvals, Market Authorisations, Labelling Services, Regulatory Submissions, Regulatory Reporting, Regulatory Intelligence, Authorised Agent Services.