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Nutraceutical Health Claim Substantiation and Novel Food Dossiers
Pubrica supports nutraceutical, food and ingredient companies with health claim dossiers, substantiation files and novel food applications for products regulated under food law. We prepare Article 13.5 and 14 applications to EFSA guidance, systematic reviews, human intervention study reports and safety assessments. A food safety authority assesses whether a cause-and-effect relationship is established, not clinical efficacy, so we structure each dossier around that question and check that the evidence matches the proposed claim wording.
We check that the proposed claim wording matches the evidence.
- Food law, not medicines law
- Claim wording matched to evidence
- Evidence feasibility assessment
- Mutual NDA on request
- You remain the applicant
Service Scope
Health claim dossiers structured for food safety assessment
Health claim applications are assessed on whether a cause-and-effect relationship is established between the food and the claimed effect, in the general population, at a realistic intake. We structure the evidence to address each of these points.
Structured around
Cause and effect
The specific relationship the authority assesses, rather than clinical efficacy.
Matched to
The claim wording
The evidence must support the exact claim wording proposed, a common point of failure.
Defined by
The target population
Evidence in a deficient or diseased group rarely supports a general-population claim.
Our Services
Dossiers, reviews and study support for health claims
Available singly or as a full dossier. The scoping read includes an assessment of whether the evidence can support the claim.
Deliverables and the guidelines that apply
Services for this sector
Full list of services for nutraceutical and food companies
Services are grouped by type of work, from evidence synthesis and study design to safety documentation, publication and content. Services governed by a different regulation are listed on the relevant sector page.
42 services, grouped
Services can be commissioned singly or together. When several run at once, one named lead coordinates them so the documents stay consistent.
Who We Serve
Nutraceutical and food teams we support
The free scoping read is tailored to the role and needs of the person commissioning the work.
Who we work with
Our compliance and guideline standards
Food regulations and guidance we apply
We work to the current edition of food law and guidance. Where a standard has been updated recently, the deliverable states which version was used.
Regulations and standards
Where AI is used, and where it is not
AI tools support search and formatting only. They are not used to write your science.
This policy applies to every service and sector, regardless of deadline.
Our AI policy
How it works
A five-step process, starting with a free scoping read
We review your material before providing a quote.
One
Scoping read
Two business days, no cost. What the work needs, who would hold it, what it would cost.
Two
Named team
You are told who is assigned and what they have worked on, before anything starts.
Three
Outline signed off
Every section, what goes in it and its source — approved before drafting.
Four
Draft and review
Independent review, quality control and reference verification, each signed off separately.
Five
Handover
The deliverable with its working material, version-controlled and revised within the agreed scope.
Throughout
One named lead
The same lead throughout the project, keeping documents consistent.
What you provide, what we provide
Share your existing material and we will identify what is missing.
Most projects start with incomplete material, so the scoping read includes a review of what is available.
You send
The source
Existing material, your templates and the required completion date.
We send back
A written view
What is there, what is missing, and what condition the existing material is in.
Then
A scope and a figure
Quoted per dossier, with the named team and the timeline, before you commit.
Our Experts
Qualified writers, statisticians and reviewers
Work is assigned by subject and sector. Writers hold a master’s degree or a doctorate in life sciences, medicine, pharmacy or the relevant discipline, and at least five years in the field. Where the work is governed by specific guidance, keeping current with that guidance is part of their role.
Specialists assigned to nutraceutical projects
Sample work
Examples of completed deliverables
Published with client agreement and redacted where requested.
Benefits
Benefits for nutraceutical and food companies
The benefits clients most often mention.
What you get
Packages
Pricing is quoted per dossier, not per page.
Pricing by word count does not reflect the work involved. The free scoping read gives you a quote you can include in a budget.
First
Scoping read
Free, two business days. A written assessment of what the work needs.
Then
A written scope
Deliverables, standards, named team and timeline, agreed before work starts.
Quoted
Per dossier
One figure for the scope agreed, with revisions inside it rather than billed per round.
Quality Assurance
Revisions within the agreed scope
If the deliverable does not meet the scope you approved, we rework it within the agreed scope at no further charge and repeat the independent review.
What the guarantee covers
FAQs
Common questions from nutraceutical and food companies
The most common reasons are that the evidence does not match the claim as worded, or that it comes from a population the claim does not cover. A trial in people with a deficiency may not support a general-population claim. Another frequent reason is that the measured outcome is not accepted as a beneficial physiological effect, which can be checked before the study begins.
Yes. This is a key part of the scoping read. A failed application is public, and a rejected claim is harder to revisit than one not yet submitted. We advise early if we expect the evidence will not support the claim.
Yes, and this is when advice is most useful. Endpoint, population, intake and duration all affect whether the results can support a claim, and they can only be changed before the study starts.
No. Health claims fall under a different regulation, a different authority and a different evidence standard. A dossier structured like a CTD submission does not address the question a food safety assessor is asking.
Yes. Authorised wording and marketing wording often diverge, and enforcement authorities assess the wording on pack. We identify where it has moved beyond what was authorised; enforcement advice should come from a lawyer.
We do not run studies, give legal advice on enforcement risk, or write marketing copy beyond what the evidence supports. If a proposed claim is unlikely to be supported by the dossier, we tell you.
Related services
Related sectors and services
Projects that span more than one sector are staffed with specialists from each.
Other sectors and other ways in
Discuss your nutraceutical dossier requirements
The scoping read is free and takes two business days. You receive a written assessment of what the work needs and who would lead it.