eLeaflet
Validation.
Already have ePIL or eLeaflet documents? We validate every resource against FHIR R4 specifications, JFDA requirements, and EMA guidance — identifying compliance gaps before a regulator does.
of first-submission ePIL rejections are due to FHIR structural errors that a conformance audit would have caught.
average delay caused by a failed JFDA ePIL submission — a risk that a pre-submission audit eliminates.
of NASHRA-audited ePIL portfolios passed first-submission JFDA review.
Comprehensive compliance validation.
We don't just check a checklist — we simulate what a JFDA or EMA inspector would find in your ePIL documentation.
FHIR R4 Conformance Audit
Line-by-line validation of your existing ePIL or eLeaflet resources against HL7 FHIR R4 specifications. We identify invalid resource structures, missing required fields, and incorrect terminology bindings.
JFDA & EMA Compliance Review
Expert review of your electronic package inserts against current JFDA and EMA guidance. We produce a gap analysis report with prioritized remediation steps for each non-conformance.
Content Accuracy Audit
Cross-reference your ePIL content against approved SmPC, marketing authorization records, and JFDA registration data to identify inconsistencies before they reach a regulator.
Risk & Gap Analysis
Comprehensive risk scoring of your current eLeaflet portfolio — identifying high-risk products with structural, clinical, or regulatory gaps that could trigger inspection findings.
Audit Readiness Assessment
Simulate a JFDA or EMA inspection audit of your ePIL documentation. We evaluate audit trail completeness, version control integrity, and data traceability across your system.
Remediation & Certification
After the audit, our engineers fix identified issues and provide a signed remediation report — confirming your ePIL portfolio is submission-ready.
Every audit includes:
- Detailed FHIR R4 conformance report per product
- JFDA / EMA gap analysis with remediation priority matrix
- Audit trail completeness score
- Content accuracy cross-reference report
- Corrected FHIR resource files (post-remediation)
- Signed audit completion certificate
How many products need auditing?
Tell us your product count and current ePIL format and we'll give you a scope and timeline within 24 hours.
Request an Audit