Manual claim identification
Reviewers read documents line by line looking for promotional claims — time-consuming and inconsistent between reviewers.
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For most pharma and biotech companies, Medical, Legal & Regulatory review is the biggest bottleneck between creating content and getting it to market. This guide explains how the process works, why it takes so long, and how AI-powered platforms like ERMA cut review times by more than 60%.
Whether you're reviewing a sales aid, website, email campaign, congress booth, patient brochure, or social post, every promotional piece passes through multiple reviewers before publication — each evaluating content from a different perspective.
COMMON REVIEWERS
| REVIEWER | PRIMARY RESPONSIBILITY |
|---|---|
| Medical | Scientific accuracy and evidence |
| Regulatory | FDA compliance and labeling consistency |
| Legal | Risk management and promotional compliance |
| Marketing | Brand strategy and messaging |
| Medical Writer | Content quality and supporting references |
Every organization has its own workflow, but several bottlenecks are nearly universal.
Reviewers read documents line by line looking for promotional claims — time-consuming and inconsistent between reviewers.
Every efficacy, safety, or clinical claim must be tied to approved evidence — searching PDFs, study versions, and citations by hand.
Draft → Medical → Marketing → Regulatory → Legal → Approval. A single change can trigger another full cycle.
Email chains make it hard to know which version is current, who approved, and what comments are outstanding.
Traditional systems only recognize claims someone already entered — new wording or evolving language is easily missed.
Workflows vary, but a typical promotional review moves through eight stages.
Marketing or Medical creates the promotional content.
Publications, prescribing information, and internal references are attached.
Content enters the review system and reviewers are assigned.
Reviewers verify scientific accuracy, clinical context, and appropriate references.
Regulatory confirms alignment with approved indication, FDA guidance, labeling, and fair balance.
Legal evaluates promotional risk and compliance.
Comments are consolidated and revisions are made.
Approved materials are archived with complete audit history.
Rather than replacing reviewers, AI assists them by automating repetitive tasks and surfacing potential issues earlier. Human reviewers remain responsible for final approval.
Instead of relying on static claims databases, ERMA analyzes each document dynamically — so reviewers spend less time searching and more time making informed decisions.
Identifies promotional and medical claims automatically — no manually maintained claims database required.
Reviewers receive AI-generated suggestions for the most relevant supporting references instead of searching dozens of PDFs.
Search FDA guidance, warning letters, and regulatory resources directly within the review workflow.
Configurable workflows by brand, therapeutic area, content type, review roles, and approval paths.
Medical, Legal, Regulatory, Marketing, and agencies work in one platform with version control and centralized commenting.
Every comment, approval, document version, and workflow action is tracked for inspection readiness.
Regardless of technology, most organizations benefit from the same foundational habits.
Create consistent review paths for different content types.
Maintain one approved source of scientific evidence.
Automate repetitive administrative tasks wherever possible.
Track review status through dashboards instead of spreadsheets.
The best results occur when AI supports Medical, Legal, and Regulatory professionals rather than attempting to replace them.
MLR stands for Medical, Legal, and Regulatory review.
MLR helps ensure promotional materials comply with FDA regulations, product labeling, and internal compliance standards before reaching healthcare professionals or patients.
Traditional reviews often take several weeks depending on complexity, reviewer availability, and revision cycles. AI-enabled workflows can significantly reduce review times by automating repetitive tasks and streamlining collaboration.
No. AI is designed to assist reviewers by identifying claims, organizing references, and automating workflow tasks. Final compliance decisions should always remain with qualified Medical, Legal, and Regulatory professionals.
Examples include:
Real solutions for real MLR challenges