Convert existing Product Information into structured FHIR ePI, validate it against EMA ePI and QRD requirements and manage every version across your portfolio.
ePIverity gives Regulatory and Labeling teams a controlled workflow from today's Product Information to electronic Product Information.
For decades, Product Information has primarily lived in documents.
European electronic Product Information introduces a structured, machine-readable format for authorised Product Information.
That creates a new operational challenge for pharmaceutical companies:
ePIverity is built for that transition.
Bring in your existing Product Information.
Start with:
ePIverity preserves the original source and keeps every transformation traceable.
ePIverity maps the document into the relevant ePI and QRD structure.
Sections, headings, paragraphs, tables and metadata are transformed into structured Product Information.
AI can assist with mapping.
It never silently rewrites your approved medicinal content.
Run technical validation before the ePI reaches the regulatory submission process.
ePIverity checks:
Problems are shown directly where they occur.
Instead of receiving a technical validator output, Regulatory teams get actionable review tasks.
Compare the source document and generated ePI side by side.
See exactly where every piece of content came from.
Once the ePI passes your internal review and technical validation:
Download the FHIR package for import into the EMA PLM Portal.
The regulatory submission and approval process remains with the relevant authority.
ePIverity prepares the ePI for that process.
One medicine is manageable.
Hundreds of products across markets, languages and continuous regulatory changes are an operational challenge.
ePIverity gives teams a portfolio view of ePI readiness.
Filter by:
Know exactly where your ePI transition stands.
Regulated content should not disappear into an AI black box.
For every structured ePI element, ePIverity keeps the relationship to its original source.
Regulatory reviewers can inspect that relationship before approving the output.
A technically valid XML file is not enough.
ePIverity evaluates the document against the structures expected for electronic Product Information.
Validate resources against the applicable profiles.
Identify missing, duplicated or incorrectly structured sections.
Check relevant Product Information metadata.
Detect malformed XML, XHTML and document relationships.
Generic document comparison tells you which words changed.
ePIverity shows where the Product Information changed.
Understand changes by document and QRD section instead of reviewing an undifferentiated text diff.
Approved internal versions are immutable.
New Product Information creates a new version instead of silently changing the old one.
ePIverity does not replace the EMA PLM Portal or the regulator.
It is designed around the European ePI standard and FHIR architecture, and is version-aware as that standard evolves. The workflow is deliberately clear:
creates and reviews Product Information
structures and technically validates ePI
official regulatory submission workflow
reviews and publishes authorised ePI
This separation keeps the roles clear.
Creating the ePI should not be the end of its lifecycle.
Once an authority publishes the authorised ePI, ePIverity can synchronise the published version back into your controlled environment.
That enables teams to compare:
and keep a verified record of the current authorised version.
ePIverity is not another RIM replacement project.
Continue using your existing:
ePIverity adds the ePI transformation and lifecycle layer.
You do not need to migrate an entire portfolio before proving the workflow.
Prove the workflow on a handful of products first. The platform subscription follows once you know what portfolio-scale migration involves.
No.
The EU is transitioning towards ePI and implementation is being rolled out progressively.
EMA has stated that ePI will become mandatory for newly authorised medicines once the revised EU pharmaceutical legislation becomes applicable.
ePIverity is designed to help organisations prepare their processes and portfolios for that transition.
Not in the initial product.
ePIverity prepares and technically validates the ePI.
Your authorised Regulatory user imports the FHIR into the EMA PLM Portal and manages the official regulatory submission process.
This keeps ePIverity separate from the role of the regulator.
The PLM Portal is the official regulatory environment.
ePIverity addresses the operational work that happens around it:
The goal is not to replace PLM.
The goal is to arrive at PLM with a controlled, validated ePI.
It means the ePI has passed the configured technical validation and internal review workflow for export into the official submission process.
It does not mean that EMA or another authority has approved the Product Information.
Regulatory approval remains with the relevant authority.
No.
ePIverity is designed to integrate with the systems you already use.
It acts as an ePI transformation, validation and lifecycle layer.
Yes.
ePIverity is designed to ingest existing Product Information and map it to the appropriate structured ePI representation.
Automated mapping remains reviewable before the output is approved internally.
PDF support can be provided for legacy content, although structured source formats such as Word provide better information for reliable automated conversion.
Yes, selectively.
AI can support structure recognition, section mapping and information retrieval.
Deterministic validation and human approval remain separate from AI-based suggestions.
ePIverity can retrieve and store the authority-published version where supported by the relevant regulatory interface.
This creates a controlled record of the current authorised Product Information and enables downstream delivery.
No.
Verified Search is an optional downstream capability.
It uses structured, authority-published Product Information to make specific passages easier to find.
No.
Its purpose is to locate and return the relevant original passage from authorised Product Information.
Book a 15-minute ePI readiness call or send us a message. We usually reply within one business day.
Pick a time. We'll look at your portfolio, your source formats and whether a pilot makes sense.
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