eLeaflet
Building.
The end-to-end platform for pharmaceutical companies to author, validate, and distribute FHIR R4-compliant electronic package inserts (ePIL) and eLeaflets. Powered by AI — compliant with JFDA, EMA, and FDA standards.
Everything your ePIL workflow needs.
From content authoring to regulatory submission — one integrated system for pharmaceutical leaflet management.
ePIL Authoring Platform
Structured authoring environment for writing and versioning electronic package inserts. Supports multi-language content, role-based review workflows, and one-click FHIR R4 export.
AI-Assisted Leaflet Generation
Convert existing paper leaflets, Word documents, or PDF SmPCs into structured, FHIR-compliant ePIL XML using our AI extraction engine. Reduces manual effort by over 90%.
JFDA & EMA Compliance
Every leaflet produced is validated against JFDA, EMA, and FDA structural requirements before export. Built-in schema validators flag non-compliant fields in real time.
Multi-Product & Multi-Market
Manage hundreds of products across multiple markets from a single platform. Country-specific variants, language packs, and regulatory profiles are handled automatically.
HL7 & FHIR R4 Export
Generate fully structured HL7 FHIR R4 XML or JSON resources: MedicinalProductDefinition, ClinicalUseDefinition, PackagedProductDefinition — ready for regulatory submission.
Audit Trail & Version History
Every edit is logged with a timestamp, user identity, and reason for change. Full version diff view and rollback for complete GxP traceability.
From raw document to compliant ePIL.
Our 4-step process takes your existing leaflet content and transforms it into a validated, submission-ready FHIR R4 resource.
Content Ingestion
Import existing SmPC documents, Word files, or legacy PDFs. Our AI extracts structured sections automatically.
Structure & Validate
Map content to FHIR resource fields with real-time validation against JFDA and EMA schemas.
Review & Approve
Medical and regulatory teams review in a structured workflow with tracked changes and approval sign-off.
Publish & Distribute
Export validated FHIR XML/JSON and distribute to national health registries, pharmacies, and QMS systems.
NASHRA ePIL Platform
NASHRA is our production-ready eLeaflet building platform, already deployed at pharmaceutical distributors operating under JFDA oversight. It transforms the most complex SmPC documents into FHIR R4-compliant XML in under 3 minutes — with 100% audit traceability and zero human error on structural validation.
Ready to digitize your leaflets?
Whether you have 5 products or 500, our platform scales to your portfolio. We'll walk you through a live demo with your own documents.
Book a Demo