Accelerate your transition to EMA-ready ePI.
Move from legacy leaflets to EMA-ready ePI.
Leaphy helps pharmaceutical organisations convert Word and PDF product information into structured, FHIR-compliant electronic Product Information with AI-supported conversion workflows, built-in quality control, and a path toward scalable ePI operations.
AI-supported conversionHL7 FHIR-aligned outputMetadata-driven workflows
Portfolio readiness
AI-supported ePI conversion
PIL source
PDF / Word
SmPC source
Word
Package data
GTIN / language
Structure
AI assisted
Metadata
Mapped
QC
Reviewed
FHIR XML
Prepared
FHIR ePI package
Structured output for readiness review
IngestStructureCheckPrepare
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.
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.
Market inflection
ePI readiness is no longer a future planning exercise.
Pharma organisations are moving toward structured, digital, FHIR-based electronic product information. Manual document workflows create operational risk, rework, and delays when portfolio-scale readiness is required.
Manual conversion does not scale
Metadata and structure matter
PLM readiness requires validation
Multi-country portfolios need repeatable workflows
Current risk
Manual conversion creates delay, rework, and submission risk.
Legacy files, repeated QA, uncertain FHIR mapping, and missing metadata make portfolio rollout harder than it needs to be.
Legacy Word/PDF files
Manual extraction
Broken tables/images
Missing metadata
Repeated QA checks
FHIR mapping uncertainty
PLM import risk
Slow rollout
Solution
A faster path from document-based leaflets to structured ePI.
Leaphy converts existing Word/PDF product information into structured HTML and FHIR-compliant XML, with AI-supported structuring, quality control, and metadata support to help teams prepare cleaner outputs for validation and PLM import.
Word/PDF ingestion
AI-supported content structuring
Internal quality control
Metadata enrichment
FHIR XML generation
PLM readiness support
How it works
From source document to EMA-ready output.
A controlled workflow moves source files through structure, quality control, FHIR XML generation, and readiness review.
Prepare source files
Word/PDF input, product metadata, language, country, GTIN/FMD code where available.
Convert and structure
Use AI-supported conversion workflows to transform content into structured HTML and generate FHIR-compliant XML aligned to the EMA ePI Common Standard context.
Quality control and readiness
Check structure, formatting, tables, images, metadata, and readiness for validation/import.
Word/PDF -> AI-supported structuring -> QC -> FHIR XML -> PLM readiness
Differentiation
Built for pharma teams that need speed, control, and scalability.
Leaphy turns conversion into a repeatable readiness workflow, not a one-off formatting exercise.
| Area | Traditional manual path | Leaphy path |
|---|---|---|
| Source handling | Manual document extraction | Controlled Word/PDF ingestion |
| Metadata handling | Separate spreadsheets and gaps | Metadata enrichment support |
| Quality control | Repeated manual checks | Built-in structure and formatting QC |
| XML generation | Late-stage uncertainty | FHIR-aligned output preparation |
| Portfolio scalability | Hard to repeat | Designed for repeatable rollout |
| Submission readiness | Higher rework risk | Cleaner readiness workflow |
Pharma services
Engagement models for every stage of ePI maturity.
Start with a pilot conversion, expand into portfolio readiness, or plan strategic ePI operations.
Project-Based Conversion
Best for pilot projects, initial readiness, and selected products.
Start a pilotPortfolio Conversion Program
Best for medium and large portfolios, multi-country product ranges, and repeatable rollout.
Discuss your portfolioManaged ePI Services
Best for ongoing updates, metadata maintenance, conversion support, and operational continuity.
Explore managed supportStrategic Partnership
Best for enterprise governance, integrations, workflow orchestration, APIs, resolver services, and long-term ePI operations.
Plan your ePI roadmapApp & access
Turn compliance work into reusable digital product information.
The Leaphy app is a downstream access channel for structured ePI content, supporting patient access and future interoperability.
Better patient access through the Leaphy app
2D Matrix / GTIN-enabled discovery
Structured multilingual product information
API-ready distribution
Corporate website and partner integration
Future interoperability with healthcare systems
Future vision
From conversion readiness to connected ePI operations.
Conversion is the entry point. Operational enablement and interoperability are the strategic destination.
Compliance Readiness
- PDF/Word -> Structured ePI
- FHIR conversion
- Submission readiness
Operational Excellence
- Validation
- Governance
- Quality management
- Workflow support
- RIM integration readiness
Connected Ecosystems
- Enterprise integrations
- Distribution APIs
- Resolver services
- Healthcare systems connectivity
Trust
Aligned with the direction of structured digital medicine information.
Leaphy is designed for pharma, regulatory, and healthcare information workflows while avoiding unsupported claims about certification, approval, or guaranteed acceptance.
EMA ePI Common Standard context
HL7 FHIR-based structured output
Metadata-driven leaflet management
Regulated workflow orientation
Existing app and access capabilities
ePI Knowledge Hub
Explore ePI readiness topics.
AI-search friendly pages explain the core concepts, workflows, and high-intent service areas for pharma teams.
Final CTA
Ready to understand how fast your portfolio can move?
Book an ePI readiness call, request a pilot conversion, discuss your portfolio, or contact Leaphy for a tailored proposal.
Book an ePI readiness call
Request a pilot conversion
Discuss your portfolio
Contact Leaphy
Send ePI readiness request
Share your portfolio context and preferred starting point.