Claims Substantiation: Keep Marketing Bold and Compliant

Marketing wants bold statements. Regulators demand defensible evidence. Without a

system, you end up rewriting copy at the eleventh hour or—worse—launching claims

that cannot be defended later.

This playbook balances creativity with compliance. You will curate an evidence

library, run disciplined review checklists, manage expiry dates, and monitor

performance so every claim stays accurate throughout its lifecycle.

Why strong substantiation matters

Regulatory trust: Health authorities expect promotional material to match

the label and be backed by sound evidence. Violations trigger warning letters

and corrective actions.

Brand credibility: Physicians, payers, and patients rely on truthful claims.

One misstep damages reputation.

Operational efficiency: A structured approach shrinks review cycles and

reduces rework.

Strategic agility: With a ready library of vetted claims, marketing teams

can respond quickly to market opportunities.

Step 1: Build a shared evidence library

Centralize clinical studies, health economics data, real-world evidence, and

internal analyses that support each claim.

Tag entries by jurisdiction, indication, therapeutic area, claim type (efficacy,

safety, convenience), and label section.

Record provenance, approval status, and links to source systems or publications.
Store the library in a controlled platform with versioning, access control, and

search capabilities.

Step 2: Define claim taxonomies and templates

Classify claims into core categories (label-based, comparative, patient support)

with clear criteria.

Provide templates that outline required elements: claim statement, supporting

evidence references, market scope, intended channel, and expiry date.

Ensure claims align with approved labeling; flag any requests needing

regulatory escalation.

Step 3: Implement role-based review checklists

Design checklists for medical, regulatory, legal, and commercial reviewers.
Require explicit references for every statement with page/figure citations.
Include risk questions: Is the claim aligned with the label? Are comparators

fair-balanced? Are disclosures present?

Capture decisions, comments, and approvals in one system to maintain an audit

trail.

Step 4: Manage claim lifecycle and expiry

Assign review dates based on evidence maturity, competitor activity, and

regulatory changes.

Automate reminders for upcoming reviews; escalate overdue claims to owners and

QA.

Archive or update claims when labels change, new safety data emerges, or

supporting studies lose relevance.

Track regional variations and ensure localized claims remain aligned with local

labels and regulations.

Step 5: Train teams and drive adoption

Educate marketing and agencies on how to request claims, access the library,

and prepare evidence packets.

Provide quick reference guides and office hours to resolve questions.
Embed usage expectations in agency contracts and brand guidelines.

Metrics that prove success

Claim creation and approval cycle times by channel.
Percentage of claims with current evidence and on-time reviews.
Rate of first-pass approvals versus iterations.
Number of claims retired proactively versus reactively.
Regulatory or medical review findings tied to insufficient substantiation.

45-day roadmap

Days 1-10: Inventory active claims and document existing supporting

evidence. Identify gaps.

Days 11-20: Configure the evidence library, migrate assets, and define

metadata standards.

Days 21-30: Build review checklists and templates, pilot them on upcoming

campaigns, and refine based on feedback.

Days 31-45: Launch the lifecycle management process with automated

reminders, measure cycle time improvements, and share metrics with

stakeholders.

Frequently asked questions

Who approves claims? Typically medical affairs or regulatory affairs with

marketing input. Define roles clearly to avoid bottlenecks.

How do we handle global versus local claims? Maintain a core global library

and extend with regional variants that reference local label differences and

evidence.

What about digital channels? Apply the same substantiation rules. Capture

hashtags, banners, and landing pages as distinct claims when messaging differs.

Can agencies access the library? Yes, with controlled permissions and NDA

coverage. Monitor usage and audit logs.

Sustain the win

Review the claim portfolio quarterly, refresh the library as new data emerges,

and rotate checklist owners so expertise spreads. Celebrate campaigns that pass

review on the first round to reinforce discipline. When claims are backed by

ready evidence, marketing stays bold—and compliant.