TejhanaConsulting LLP
Clinical studies, explained

From the first question to a claim you can defend

Four diagrams that show how we decide whether your product needs a study, how compliance is built into every stage, and how evidence becomes wording on your pack.

01

Does my product need a clinical study?

Our most common question, as a decision path. Many products need only careful claim wording, not a new study.

Decision path. Health, function or disease-risk claim? If no, no study is needed beyond FSSAI labelling rules. If the claim is already permitted, use the permitted wording. If the product is a drug or regulated product, a regulatory trial under the NDCT Rules is required. If published evidence matches the ingredient, dose and population, an evidence dossier may be enough. Otherwise, plan a human clinical study.
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02

Study pathway with standards

Each stage of a study, with the standards we plan for at that stage. Compliance is designed in, not checked at the end.

Eight study stages and their standards: feasibility and claim strategy; protocol and study design; ethics approval and registration (CTRI; NDCT where applicable); recruitment and informed consent; study conduct and monitoring; data management and analysis; reporting and publication; claim substantiation dossier.
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03

Who we work with

The clients we support, the question each one usually brings, and how we help.

Six client types: food and beverage brands, nutraceutical and supplement companies, ingredient suppliers, start-ups and new brands, hospitals and research teams, and marketing and regulatory teams.
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04

From evidence to claim

Each link in the chain must hold. A claim is only as strong as the weakest step behind it.

Chain: ingredient and dose, evidence, results, substantiation dossier, claim wording, label and marketing.
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These diagrams are general guidance, not regulatory advice. The right route depends on your product and claim. Tell us about your project and we will suggest the route that fits.