Claim strategy & substantiation.
Defensible claims and the evidence they require, aligned to EFSA, FDA and consumer-health frameworks. Built for products where the label is the promise.
The work, made concrete.
Not a service brochure, the actual scope, the actual deliverables, and how it plugs into ECS®.
- Claim architectureStructure- and function-level claims, health claims, risk-reduction claims, grouped by the evidence they need and the review body they face.
- Evidence-to-claim mappingExisting literature and prior studies triaged against each candidate claim: what supports it, where the gap sits, and what closes it.
- Substantiation study designHuman studies designed to fill the specific evidence gap, sized precisely to the review threshold.
- Dossier supportClaim dossiers written for the review body that will read them.
Every deliverable has a name on it.
What you receive.
Every engagement lands with named artefacts you can use.
- Claim architecture & prioritisation
- Evidence-to-claim gap map
- Substantiation study designs with feasibility
- Claim dossier (EFSA / FDA / competent-authority-ready)
ECS® carries the same substantiation study through recruitment, home visits and eCOA, so the evidence that shows up in the dossier is the evidence that was actually generated.
Three moments this service earns its place.
If any of these describe where you are, this is the right entry point.
- Moment 01
You're preparing a launch and the claim is still taking shape.
- Moment 02
A prior claim dossier came back with objections.
- Moment 03
You need to strengthen medical equity around an existing product.
Often engaged together.
Evidence strategy & study design
Map the evidence path, position the product scientifically, and design protocols and endpoints across every domain and product class.
Learn moreRegulatory strategy, submission and market access
Route to approval and route to reimbursement: feasibility, EMA/FDA and MDR/IVDR pathways, submissions, HEOR and payer dossiers.
Learn moreAIRA insight, advisory & AI
Three service lines: Advisory, Insight Generation and AI Applied, from research strategy to AI-assisted reads.
Learn moreTalk to the team about this service.
Tell us the study or the question, we'll come back with a scoped answer.