Claims Validation
& Seal, Built to Withstand Scrutiny
For brands and manufacturers that want microbiome claims they can stand behind. Validate product efficacy through rigorous, claims-ready studies — and earn a seal that reflects real biological performance.
claims
& higher
standard seal
Microbiome claims lack consistent standards
Microbiome claims are complex, and there is no unified regulatory framework defining what a “microbiome seal” should represent. Validation approaches vary widely—often lacking rigor, consistency, or alignment with claim intent.
Data may be inconsistently measured, loosely interpreted, or disconnected from meaningful biological benchmarks. As a result, some seals carry little scientific weight—while teams that want to do it right face uncertainty about what “rigorous” truly means.
With the right framework, validation becomes defensible—and earned
Clear standards, structured methodologies, and microbiome-specific evaluation criteria create credibility.
When validation is aligned to claim intent, measured against defined biological benchmarks, and reviewed through a consistent scoring framework, evidence becomes something teams can confidently stand behind. A seal becomes meaningful—because it reflects measurable performance, not marketing language.
HelloBiome is your partner for defensible claims and a higher standard seal
Our role is to deliver microbiome intelligence — clean, defensible data aligned to your claim intent and translated into outputs your team can actually use.
How Clinical Claims Studies Work
From study design to claims-ready outputs — in as little as three days.
1. Design
Study Design
We build a study protocol around your ingredient or formulation — including IRB review when applicable — so every result is scientifically and ethically defensible from the start.
2. Recruit
Targeted Recruitment
and At-Home Sampling
Participants are selected to match your target consumer profile — ensuring results reflect the real people your product is designed for.
3. Collect
At-Home Sampling
and Consumer Perception Data
In vivo samples are collected through decentralized protocols — at home, in clinic, or within an existing CRO-led study — with no disruption to current workflows.
4. Analyze
Advanced Sequencing and Analysis
We analyze bacteria and fungi at the species level across the full microbiome — turning raw biological data into clear, interpretable results.
5. Claim
Claim Ready Report and Certification
You receive claims-ready datasets, reporting, and the evidence needed to support product positioning across regulatory, retail, and consumer channels in just a few days.
Why HelloBiome
is your partner of choice
for claims validation
Because defensible microbiome claims start with studies designed to withstand scrutiny.
HelloBiome Intelligence
Your biological framework for interpreting claim-relevant microbiome change
HelloBiome Intelligence provides the standardized biological context needed to interpret microbiome data in relation to specific claim intent. By applying consistent scoring, clustering, and benchmarking, we translate microbiome change into evidence that is structured, comparable, and defensible—so claims are grounded in biology, not interpretation gaps.
Clinical Claims Studies
Generate validated biological evidence aligned to claim intent
Clinical Claims Studies are designed to evaluate how products impact the microbiome in direct support of defined claims. Using validated protocols and structured outputs, these studies generate claim-ready biological evidence that teams can confidently stand behind—internally, with partners, and under regulatory scrutiny.
Ready to validate
your claims
We’ll help you determine the right approach for your microbiome evidence.