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A practical route from proposed wording to an evidence file that supports confident review.
Pathway Medical · Consumer health medical affairs · 2026
Define the wording, audience, product and context before searching for evidence. The meaning of the claim determines the evidence question.
Assess relevance, quality, consistency and limitations. Create a traceable line from each phrase to the evidence that supports it.
Record the wording, search approach, evidence table, critical appraisal, conclusion and source documents in one controlled file.
Consider headlines, imagery, qualifiers, testimonials and calls to action together, then keep the substantiation file current after launch.
Substantiation is not a one-off exercise. New evidence, reformulation, competitor activity and changes to executions can affect the position. Agree ownership and a proportionate review cadence so the claims file stays useful after launch.
Frequently asked questions
The evidence must be relevant to the exact claim, ingredient or product, dose, population and conditions of use. Confirm the applicable UK framework first and record the reasoning in a clear substantiation file.
Only with care. Rewording can alter the consumer meaning or create a stronger implied promise than the authorised wording supports. Review the full execution against the relevant register and code.
Not usually on its own. Consider study quality, relevance, consistency with the wider evidence and important limitations. The conclusion should explain why the total evidence supports the wording used.
Medical review should begin while the claim territory and creative route are still flexible. Early review helps protect the commercial idea, identify evidence gaps and avoid late-stage changes.
Update it when wording, formulation, target audience, evidence or the regulatory context changes. For important in-market claims, agree a periodic review proportionate to risk and business value.
Use this paper as a starting point, then apply the framework to the exact product, evidence position and decision in front of your team.
Discuss the paper →CE
Build defensible claims, evidence plans and publication-ready scientific narratives.
Explore service →MR
Review claims and copy early so the core idea remains evidence-led and approval-ready.
Explore service →RS
Navigate classification, claims and evidence requirements with practical scientific guidance.
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