Full-service compliance,
handled by our experts.
Don't have the internal regulatory staff to build ePI leaflets? NASHRA's medical compliance experts manage the entire transformation lifecycle under strict SLAs — with full regulatory liability.
Per-leaflet service pricing
Fixed-rate pricing for both initial builds and ongoing versioning — no hidden fees or scope creep.
| Leaflet Type | Building | Versioning |
|---|---|---|
Patient Information Leaflet (PIL) Patient-facing leaflets. End-to-end digitizing of inserts, clinical translation, and structural JFDA compliance. | 175 JODper leaflet | 100 JODper version |
Summary of Product Characteristics (SmPC) Healthcare professional summaries. Complex administrative mapping, ingredient composition coding, and FHIR resource construction. | 200 JODper leaflet | 125 JODper version |
Regulatory Tech Consultation
Dedicated consulting for FHIR HL7 integration, JFDA-alignment, workflow automation, and custom model setups.
The Regulatory Liability Split
Self-Service: Using our SaaS plans places full regulatory, translation, and compliance responsibility on your own regulatory affairs team.
Managed Engagements: Choosing Managed Services transfers complete content integrity, clinical translation correctness, and structural JFDA/FHIR compliance liability entirely to NASHRA.
Prefer to self-serve? View SaaS subscription plans →
Managed Services
FAQ
Common questions about our white-glove delivery model, liability, and how engagements work.
Building refers to the initial end-to-end creation of a compliant ePI leaflet — from raw source documents through clinical translation, FHIR XML structure, and JFDA compliance validation. Versioning covers updates to an existing leaflet (e.g., label changes, new safety data, regulatory amendment cycles).