Get Smarter and Efficient MLR Reviews with ERMA Evaluate™

ERMA is designed to help life sciences teams navigate the evolving landscape of FDA promotional regulations with greater confidence and control. At its core, ERMA continuously validates marketing and promotional materials against the latest FDA guidance, helping teams identify potential compliance risks before materials enter or progress through the MLR review process.

By analyzing content for claims, context, and supporting evidence, the platform flags areas that may require stronger substantiation or regulatory review, helping reduce the likelihood of OPDP warning or untitled letters.

Beyond referencing FDA regulations alone, ERMA also maintains a living knowledge base of FDA enforcement actions, guidance updates, and precedent-setting letters issued to pharmaceutical and biotech companies. This provides additional regulatory context, allowing teams to understand how the FDA has interpreted and enforced promotional standards in real-world scenarios.

In addition to validating materials against FDA guidance, the platform gives organizations the autonomy to establish their own internal compliance rules and guardrails. Teams can configure guidance frameworks that reflect their internal SOPs, incorporate learnings from previous regulatory violations, or apply company-specific standards that go beyond FDA baseline requirements.

This flexibility ensures ERMA adapts to the way organizations operate rather than forcing teams into rigid compliance structures. Regulatory, medical, and legal teams can refine and evolve their internal rules over time, creating a dynamic compliance environment that strengthens institutional knowledge and improves consistency across materials, brands, and review cycles.

• Continuous validation against the latest FDA promotional guidance
• Living knowledge base of FDA enforcement actions and precedent-setting letters
• Configurable internal compliance rules aligned to company SOPs and risk tolerance
• Dynamic rules that evolve with regulatory feedback and organizational learnings

The result is a smarter, more flexible approach to promotional compliance, one that combines FDA regulatory intelligence with the practical realities of how life sciences organizations manage risk internally.

At the core of ERMA Evaluate™ is its ability to automatically identify claims within promotional and scientific materials and assign the appropriate supporting references. When a document is uploaded, ERMA ingests the full content, including text, charts, graphs, and imagery—and breaks it down into smaller contextual segments.

The platform then analyzes the material to detect statements that may constitute clinical, safety, efficacy, or comparative claims that require substantiation. Unlike traditional systems that rely on static claims libraries or manually maintained databases, ERMA does not depend on a predefined repository of approved claims.

Once potential claims are identified, ERMA automatically recommends supporting references from the organization's reference library. The system analyzes the context of each claim and surfaces the most relevant scientific or regulatory sources, helping reviewers quickly verify that the appropriate evidence is in place.

Importantly, ERMA recognizes that claims often require multiple sentences or sections of evidence to be fully substantiated. Rather than assigning a single reference or isolated excerpt, the platform identifies all relevant supporting content needed to properly validate a claim.

• Dynamic claim detection across text, charts, graphs, and imagery
• Automatic reference recommendations from the organization's library
• Multi-sentence substantiation mapping for complete claim coverage
• Learns from reviewer decisions to improve recommendations over time

By automating the most time-consuming aspects of claim verification, ERMA allows medical, legal, and regulatory teams to focus on higher-value review decisions rather than manual administrative tasks.

MLR review rarely follows a simple, linear path. Materials often move between medical, legal, regulatory, brand, and agency stakeholders, sometimes across multiple review cycles, timelines, and priorities. ERMA was built to reflect this real-world complexity by providing highly flexible workflows that adapt to how organizations actually operate.

With ERMA, organizations can design review workflows that mirror their internal processes, including the sequencing of reviewers, approval hierarchies, and project ownership. Coordinators and project owners can easily assign reviewers, adjust timelines, reprioritize projects, or reroute materials as needed.

The platform also accommodates the reality that priorities shift. Review cycles can be shortened or extended, tasks can be reassigned, and materials can move across parallel review tracks when needed. As processes evolve, whether due to regulatory updates, organizational changes, or new product launches, workflows can be easily updated without requiring system overhauls or complex technical changes.

• Configurable reviewer sequencing, approval hierarchies, and project ownership
• Supports both PRC and MRC processes within a single platform
• Parallel review tracks for managing multiple concurrent projects
• Workflow updates without system overhauls or technical complexity

By combining flexible workflows with deep configuration capabilities, ERMA empowers organizations to build an MLR environment that truly fits their needs, improving collaboration, increasing transparency, and maintaining full compliance oversight.

MLR review is rarely static. Team members shift priorities, new stakeholders may need to be added, and materials often require additional expertise as they move through the review process. ERMA is designed to accommodate these realities by allowing tasks to be reassigned quickly and seamlessly without disrupting the overall workflow.

Within ERMA, coordinators and project owners have full visibility into the status of each review and the ability to reassign tasks as needed. If a reviewer becomes unavailable, a project requires additional expertise, or responsibilities shift between teams, tasks can be transferred to another reviewer in seconds.

• Instant task reassignment without disrupting the overall workflow
• Add reviewers mid-cycle or redirect to subject matter experts as needed
• Configurable reassignment authority aligned to internal SOPs
• Full audit trail of all transitions, reviewer actions, and timestamps

Materials remain visible, accountability is preserved, and projects continue moving forward—ensuring that operational changes do not slow down critical MLR reviews.

ERMA is designed to support the complex collaboration models that exist across pharmaceutical and biotech organizations, agencies, and external partners. Through multi-tenant access, a single user can securely access multiple client or organizational environments while keeping each tenant fully isolated.

Agencies, consultants, and internal teams can participate in multiple review environments using a single login while maintaining strict separation between each organization's materials, workflows, and reference libraries. PRC and MRC processes can also be maintained in distinct environments, ensuring sensitive materials remain appropriately segmented.

• Single login access across multiple client or organizational environments
• Full data isolation between tenants—materials, workflows, and libraries separate
• Distinct environments for PRC and MRC review processes
• New brands or partner teams added as separate tenants without disrupting existing processes

By combining secure tenant separation with flexible access across environments, ERMA enables seamless collaboration while preserving the strict compliance controls required in life sciences.

MLR reviews often involve multiple rounds of edits, comments, and revisions across different stakeholders. Tracking what has changed, and why, can quickly become difficult when teams are reviewing documents across email threads, file versions, or disconnected systems.

ERMA simplifies this process with built-in side-by-side comparison capabilities that allow reviewers to easily evaluate changes between document versions. Within the platform, users can view two versions of a document simultaneously, clearly highlighting edits, additions, and removed content.

Teams can compare different versions across multiple review cycles, track how messaging evolves throughout the process, and maintain a clear record of all revisions as part of the project's audit trail. This level of visibility supports both internal accountability and regulatory readiness.

• Simultaneous view of two document versions with changes clearly highlighted
• Verification that edits, claims, and references remain aligned after revisions
• Version history tracked across all review cycles as part of the audit trail
• Reduces review fatigue and re-review time across revision cycles

By making version changes immediately visible and easy to evaluate, ERMA reduces review fatigue, improves accuracy, and helps teams move through revision cycles faster while maintaining full oversight of the evolving content.

ERMA Evaluate is designed to work within the realities of today's life sciences technology environments, where critical data often lives across multiple systems. Through secure API access, ERMA integrates seamlessly with existing CRM platforms, legacy MLR systems, and commercial or sales infrastructure to ensure information flows efficiently across the organization.

By connecting to upstream and downstream systems, ERMA enables teams to ingest relevant data, synchronize project information, and maintain consistency across promotional review, medical review, and commercial operations. This allows organizations to preserve investments in existing technology while enhancing the overall MLR process with ERMA's AI-driven capabilities.

• Secure API access to CRM, MLR, and commercial systems
• Automated data exchange across upstream and downstream platforms
• Document synchronization and workflow trigger support
• Preserves existing technology investments while enabling modernization
• Eliminates data silos and reduces manual handoffs across teams

By integrating with existing CRM, MLR, and commercial systems, ERMA acts as a central coordination point across the life sciences technology stack, allowing organizations to modernize their MLR process without abandoning the infrastructure they already rely on.