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Convert Pharmaceutical PIs to FHIR XML
in Minutes

Multi-jurisdiction ePI conversion and validation for regulatory affairs professionals — supporting EMA and JFDA

Key Features

Upload Product Information

Drag and drop your PI as a PDF (or a Word file for EMA) for instant processing across jurisdictions

Convert to FHIR

Automatic conversion to FHIR R5 XML bundles with jurisdiction-specific section codes

Validate & Download

Jurisdiction-specific validation with downloadable XML bundles for submission

Supported Jurisdictions

Purpose-built conversion pipelines for each regulatory authority

European Medicines Agency

EMA

Convert EPAR product information to FHIR ePI bundles with QRD validation

  • SmPC, Annex II, Labelling, Package Leaflet
  • QRD section codes
  • Multi-document EPAR upload model

Jordan Food and Drug Administration

JFDA

Convert single-document product information to FHIR ePI bundles with LOINC section codes

  • SmPC, Package Leaflet
  • LOINC section codes
  • Single-document upload with metadata profiles

Built for Regulatory Compliance

100% reproducible
FHIR R5
Multi-jurisdiction validated