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Electronic Product Information

Deliver end-to-end ePI compliance and labelling governance-from readiness to lifecycle management-with AI-driven SOP digitisation, barcode validation, and gap detection, aligned to HL7 Vulcan EPI IG.

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The ePI Mandate Requires a Partner Inside the Standard

Benefits

  • Full ePI compliance visibility – across all label formats and markets
  • End-to-end ePI lifecycle – creation, conversion, submission, and post-approval
  • Every barcode is validated before dispatch – not after a complaint or recall
  • Phased delivery – compliance value starts before FHIR ePI conversion ends
  • GxP and 21 CFR Part 11 aware – compliance by architecture, not policy

Why Deevita

  • Inside the standard – active HL7 Vulcan EPI Working Group contributor, aligned as it develops
  • Phased from day one – compliance dashboards live before conversion begins
  • Pharma-regulated delivery – ePI and labelling systems proven at a global pharma manufacturer
  • Mid-market delivery model – structured engagements without global SI timelines or costs
  • Microsoft Azure partner – cloud-native delivery on Azure

Our Electronic Product Information Solutions

Readiness Assessment Report

A complete assessment of your existing label portfolio – across all source formats – identifying every compliance gap classified by severity and mandate deadline, with team readiness ratings across regulatory, IT, and data functions. Delivered as a single actionable report with clear priorities for your conversion programme.

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.

Digital Label SOP Platform

Centralized, version-controlled, GxP-auditable SOP library – with approval workflows, role-based access, and full audit trail.

Applicable Use Cases

Migrate Legacy Labels to FHIR ePI

Life Sciences – Pharma Manufacturer

Change
Problem

A pharma manufacturer holds product information across multiple legacy formats with no FHIR ePI conversion path and no internal ePI expertise. The Q3 2026 vaccine mandate deadline is approaching with no readiness assessment or conversion programme in place.

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Solution

Deevita assesses the full label estate and compliance gaps, runs an ePI Pathfinder pilot to prove the conversion path on one real label, and delivers an HL7 Vulcan-aligned migration roadmap sequenced by mandate deadline and product category.

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Impact

Full label estate assessed for FHIR ePI readiness – every compliance gap classified by severity, product category, and mandate deadline

  • ePI Pathfinder pilot validates the conversion approach before full programme commitment
  • HL7 Vulcan-aligned migration roadmap delivered – vaccines prioritized first, programme ready for immediate execution
AI Intelligence Layer for ePI Summarization and Multi-Language Interaction

Life Sciences – Pharma Manufacturer

Change
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.

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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.

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Impact
  • AI-powered ePI summarization and translation across EU language markets
  • Conversational interaction with ePI content enabled via governed Azure AI agents
  • • 21 CFR Part 11 audit trail on every AI action – Human-in-the-Loop enforcement built in
Label Management Solution

Life Sciences – Pharma Manufacturer

Change
Problem

A global pharma manufacturer managing a large multi-market label portfolio faces significant manual regulatory effort extracting, structuring, and validating label data across legacy formats – with no audit trail on AI-assisted actions and no governed process for AI use in a regulated context. Regulatory teams need AI assistance that reduces effort without sacrificing compliance governance.

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Solution

Deevita architects an AI-assisted label management solution combining intelligent label data extraction, structured output generation, and a Human-in-the-Loop governance layer – with a 21 CFR Part 11-aware audit trail on every AI action, delivered in a pharma-regulated production environment.

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Impact
  • AI-assisted label extraction significantly reduces manual regulatory effort – structured output generated from existing label formats across all markets
  • Human-in-the-Loop governance is enforced at every step – no AI output enters a regulated workflow without human review and approval
  • 21 CFR Part 11-aware audit trail on every AI action – full traceability across extraction, classification, and validation built into the architecture
  • Regulatory teams focus on review and decision – not manual data extraction and formatting

Frequently Asked Questions

The EMA ePI mandate requires SmPC, Package Leaflet, and labelling submitted as structured FHIR ePI – not Word or PDF. Vaccines mandatory Q3 2026, oncology Q4 2026, covering all EU marketing authorisation holders, including Indian generics exporters.

It defines exactly how FHIR ePI conformance is tested at submission – a gap analysis from a published version misses requirements in the current draft. Deevita contributes to writing the HL7 Vulcan EPI IG, so our assessments reflect what conformance testing will check.

Four structured outputs: FHIR R5 ePI Readiness Report, Compliance Gap Analysis classified by severity and mandate deadline, Conversion Roadmap sequenced by product category, and Platform Architecture Recommendations. Delivered by the same team that carries through to technical delivery.

Yes – ePI Compliance Intelligence dashboards are available from Phase 1 on existing data, before a single label is converted. Full label tracking and multi-market compliance monitoring activate post-conversion in Phase 2.

Yes. Indian generics manufacturers with EU marketing authorisations are subject to the same EMA ePI mandate as EU-headquartered companies. Our ePI readiness and conversion services cover all market authorisation holders regardless of where they are headquartered – with experience across EU, US, and Indian pharma manufacturers managing multi-market ePI compliance.

Replaces Word documents and shared drives with a version-controlled, GxP-auditable SOP library – approval workflows and audit trail across all sites, through a structured onboarding.

Batch-level barcode validation before dispatch – GTINs, application identifiers, and serialization elements checked against GS1, EU FMD, and DSCSA in one pass, with reason codes and remediation on every failure. Validated GTINs feed into the Packaged Product Definition FHIR ePI.

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