ePI Platform
An intelligent platform for end-to-end ePI lifecycle management-from creation to post-approval-within a single, governed system aligned to HL7 ePI standards.
Trusted by the world’s
biggest brands
Our ePI Platform Solution
Label Migration & Conversion
Convert your full label portfolio – Word, PDF, SPL, and IDMP – to structured FHIR ePI, aligned to HL7 Vulcan EPI IG, using pre-built EPI Accelerators with a GxP-compliant audit trail.
ePI Authoring
Author SmPC, Package Leaflet, and labelling as structured FHIR data – not documents – built to HL7 Vulcan EPI IG specifications.
ePI Validation & Compliance Scoring
Validate every FHIR ePI resource against HL7 Vulcan ePI IG and applicable regulatory requirements before submission – built-in compliance scoring, structured gap reports, and remediation guidance on every conformance failure.
ePI Compliance Intelligence
Live compliance status across all markets, label versions, and renewal timelines – Power BI dashboards with proactive risk ranking, renewal forecasting, and mandate timeline alignment.
ePI Content Intelligence
Ask. Summarize. Translate across global languages. Azure AI agents bring intelligent natural language access to your ePI content – with human review enforced before any output enters a regulated workflow.
ePI Accelerators
Pre-built components – SPL/IDMP to FHIR Converter, GxP Audit Trail Generator, and ePI Compliance Dashboard – deployed within EPI engagements to reduce implementation time and conformance risk.
ePI Platform Managed Services
Continuous operational partnership covering platform upgrades, regulatory configuration, workflow automation, and FHIR ePI monitoring – keeping your label management processes and full ePI lifecycle compliant and operational as your portfolio evolves.
Capabilities
Power BI
Label version dashboards, multi-market EMA and FDA status, and portfolio health metrics – available from Phase 1.
Power Automate
Renewal alerts, label change notifications, and compliance deadline reminders – triggered automatically.
Data Governance
Label version control, data lineage across markets, and data stewardship compliance across the ePI data layer.
HL7 Vulcan EPI Working Group
Deevita contributes to writing the HL7 Vulcan EPI IG – compliance monitoring and validation built against the current working draft.
Regulated SaaS Platform Development
Azure-native, GxP-aware, validation-ready – audit-trail engineering built in from day one.
Regulated Health Tech Engineering
Azure and data engineering with pharma regulatory depth, accelerated by the EPI Accelerator Library.
Regulated AI Agents
Azure AI agents for ePI summarization, EU translation, and natural language interaction – Human-in-the-Loop enforced, full audit trail on every action.
Regulatory Compliance Dashboards
Power BI on Azure – EMA and FDA compliance status, label tracking, renewal forecasting, and audit readiness. Live from Phase 1.
One Platform for the Full ePI Lifecycle
Benefits
Why Deevita
Our ePI Platform Features
ePI Portfolio Compliance Dashboard
Live label version compliance status, portfolio health metrics, and multi-market regulatory tracking across all jurisdictions – available before your first label is converted, giving compliance teams immediate visibility from day one.
ePI Platform – Enterprise Subscription
End-to-end ePI lifecycle management – authoring, conversion, submission, and post-approval – with multi-market compliance monitoring, proactive renewal alerts, and automated regulatory change alerting across your full portfolio.
ePI Platform Applicable Use Cases
Accelerating FHIR ePI Conversion with Pre-Validated Components
Life Sciences – Pharma Manufacturer
Problem
A pharma manufacturer faces a long conversion timeline building FHIR ePI components from scratch – with conformance risk at every stage and no guarantee of passing HL7 Vulcan EPI IG validation the first time.
Solution
Deevita deploys the EPI Accelerator Library – pre-validated SPL/IDMP to FHIR converter, GxP Audit Trail generator, NCPDP to FHIR bridge, and ePI Compliance Dashboard – replacing custom builds with components already tested against the current HL7 Vulcan EPI IG.
Impact
AI Intelligence Layer for ePI Summarization and Multi-Language Interaction
Life Sciences – Global Pharma Manufacturer
Problem
A pharma manufacturer operating across multiple EU language markets needs regulatory teams to work with ePI content in local languages and interact with product information via natural language – without building internal AI capability or compromising 21 CFR Part 11 compliance.
Solution
Deevita can connect the ePI Content Intelligence layer to the platform – enabling AI-powered summarization, multi-language translation, and conversational interaction with product information – with Human-in-the-Loop governance and 21 CFR Part 11 audit trail on every AI action.
Impact
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