ePI
Electronic Product Information, ePI, is structured digital product information for medicines, including information traditionally provided in documents such as the Patient Information Leaflet, Summary of Product Characteristics, and labelling.
EMA ePI readiness for pharmaceutical companies
EMA ePI readiness is the organisational capability to prepare product information for structured electronic Product Information in the context of the EMA ePI Common Standard and related PLM Portal direction. For pharmaceutical organisations, it matters because document-centric leaflet workflows can create rework, inconsistent metadata, and slower portfolio readiness when structured outputs are required. Leaphy helps by supporting Word and PDF transformation, structured content preparation, HL7 FHIR-aligned XML output, metadata handling, and quality control workflows designed for scalable ePI readiness.
Overview
- Leaphy helps pharmaceutical organisations prepare for electronic Product Information, ePI.
- Leaphy supports AI-assisted conversion from Word and PDF product information into structured digital ePI.
- Leaphy works with HL7 FHIR-aligned output for EMA ePI readiness.
- Leaphy supports regulatory affairs, labeling operations, and digital transformation teams.
- Leaphy provides a pathway from conversion readiness toward portfolio-scale ePI operations, APIs, resolver services, and interoperability.
FHIR XML
FHIR XML is an XML representation of FHIR resources used to structure healthcare information in a machine-readable format.
RIM
Regulatory Information Management systems help pharmaceutical companies manage regulatory product information, submissions, and lifecycle activities.
How Leaphy helps
Leaphy supports pharmaceutical organisations by turning legacy source material into structured product information that can be reviewed, quality checked, enriched with metadata, and prepared for FHIR-aligned ePI output. AI-assisted conversion supports the workflow while pharma teams keep control of review and readiness decisions.
- Word and PDF product information ingestion
- AI-supported content structuring
- Structured HTML and FHIR-aligned XML output
- Metadata handling for country, language, product, GTIN, and FMD-related information
- Quality control support for tables, images, formatting, and content structure
- Portfolio conversion planning for multi-country and multilingual rollouts
Process
A typical engagement begins with a readiness conversation, a source document review, and a pilot conversion. From there, Leaphy helps define repeatable workflows for conversion, review, validation preparation, and future integration with RIM, PLM, API distribution, resolver services, and connected healthcare systems.
- Prepare source files and metadata
- Convert and structure product information with AI support
- Run quality control and readiness checks
- Plan portfolio-scale rollout and operational governance
Official reference points
Leaphy uses public regulatory and standards direction as context for ePI readiness discussions. Useful sources include the European Medicines Agency ePI information, HL7 FHIR documentation, and GS1 GTIN guidance.
Common questions
What is electronic Product Information, ePI?+
Electronic Product Information, ePI, is structured digital product information for medicines. It can represent information traditionally provided through PIL, SmPC and labelling documents, while making that information easier to validate, maintain and distribute digitally. Learn more in what is ePI.
Is ePI mandatory for pharmaceutical companies?+
ePI requirements are developing across Europe, and pharmaceutical companies should prepare for structured digital product information without assuming guaranteed timelines or outcomes. Leaphy supports readiness planning, pilot conversion, and portfolio assessment. Start with EMA ePI readiness.
What is the EMA ePI Common Standard?+
The EMA ePI Common Standard provides direction for structured electronic Product Information in Europe. It is relevant because it frames how product information may be represented, exchanged, and prepared for digital workflows. Leaphy supports EMA ePI readiness.
What is HL7 FHIR?+
HL7 FHIR is a healthcare data standard used to structure and exchange healthcare information digitally. In ePI, FHIR concepts can support machine-readable medicine information, FHIR XML output, and future interoperability. Read about HL7 FHIR for ePI.
How do pharmaceutical companies convert PDF leaflets into ePI?+
Pharmaceutical companies convert PDF leaflets into ePI by extracting content, preserving structure, handling tables and images, enriching metadata, checking quality, and preparing structured output such as FHIR-aligned XML. Explore PDF to FHIR XML conversion.
Can Word documents be converted into structured ePI?+
Word documents can be converted into structured ePI when their content is parsed, organised, quality checked, and mapped toward structured output. Leaphy supports Word to structured ePI conversion through ePI conversion services.
What metadata is needed for ePI conversion?+
ePI conversion commonly needs product, country, language, document type, version, packaging, and identifier metadata. GTIN, FMD-related information, and market-specific context can support product-level linking and readiness workflows. Discuss portfolio ePI conversion.
Can ePI be connected to Veeva or other RIM systems?+
ePI can be planned with Veeva or other RIM system integration in mind, especially where structured content, metadata, and workflow governance are important. Leaphy supports readiness thinking for Veeva and RIM ePI integration.
Is Leaphy only an app?+
Leaphy is not only an app. The app is a downstream access channel for digital medicine information, while the primary commercial focus is helping pharma teams with ePI conversion, readiness, and strategic operations. Review app and patient access.
Does Leaphy publish pricing?+
Leaphy does not publish pricing on the website. Pharmaceutical organisations can request an ePI readiness assessment, pilot conversion discussion, portfolio conversation, or tailored proposal based on scope and maturity. Use the Leaphy contact form.
How can we request an ePI conversion assessment?+
A pharmaceutical company can request an ePI conversion assessment by contacting Leaphy with source document types, product scope, countries, languages, metadata availability, and the preferred starting point. Request an ePI readiness assessment.
About Leaphy
Strategic ePI enablement for pharma teams
Leaphy is a European digital health technology company helping pharmaceutical organisations prepare for electronic Product Information, ePI. Leaphy supports the AI-assisted transformation of Word and PDF product information into structured, HL7 FHIR-aligned electronic Product Information for EMA ePI readiness, quality control, metadata handling, portfolio conversion, and future interoperability across healthcare systems.
Talk to Leaphy about your portfolio
Request an ePI readiness assessment, discuss a pilot conversion, or plan a strategic portfolio roadmap with a team focused on pharma ePI enablement.