The ePI Operating System for Modern Pharma.
NASHRA transforms raw pharmaceutical documents into structured, FHIR-compliant ePI bundles — powered by AI, built for regulatory teams who can't afford errors.
Your regulatory team is still living in Word documents and spreadsheets.
Manually converting PDFs to XML. Re-entering data across versions. Praying nothing was missed before submission. NASHRA was built to end all of that.
Manual XML conversion averages 3–5 days per document. Your team deserves better.
Manual transcription introduces up to 12% structural errors before submission.
No version control means no audit trail. One change breaks the entire chain.
“That's not a process. That's a liability.”
One intelligent platform.
The complete ePI lifecycle.
NASHRA connects every stage — from document ingestion to FHIR bundle export — in a single, AI-assisted workspace your entire team can use.
Upload any source document.
NASHRA's Neuro AI Engine extracts, structures, and maps your content automatically. PDF, DOCX — any format, any layout.
Your entire portfolio. One workspace.
Manage every product, dossier, and version in a clean hierarchical workspace. MAH → Dossier → Leaflet → Version. No spreadsheets. No chaos.
One click to FHIR-compliant XML.
Generate FHIR R5 compliant XML bundles ready for JFDA submission. Built-in validation catches errors before they reach the regulator.
Not just software.
A pharmaceutical brain.
Powered by Google Gemini, the Neuro AI Engine reads, understands, and structures your pharmaceutical content with clinical precision. Not every document is clean. Not every table is structured. Neuro reads what others can't.
Neuro Extraction
Converts PDF layouts into perfectly structured digital sections. Understands PIL and SmPC formats natively — no template required.
Neuro Med
Identifies active substances, strengths, dosage forms, and maps them to FHIR-compliant terminology automatically. Clinical precision at scale.
Neuro Analytics (NeuroTVT)
A clinical-grade auditing engine. Word-by-word cross-reference between your source document and digital composition. Full audit trail.
From document to submission
in six steps.
Upload PDF or Word document. Any format, any layout.
Choose extraction level: Standard / Advanced OCR / Neuro AI.
Refine content in the premium structured editor.
AI cross-reference against source document. Word by word.
Generate FHIR-compliant XML bundle. One click.
Manage versions with full inheritance and audit trail.
Built for the standards that matter.
What regulatory teams are saying.
“NASHRA cut our leaflet preparation time from 4 days to half a day. The FHIR export alone justified the subscription — and that was just the beginning.”
“Finally, a platform that understands what we actually do. The version control and hierarchy system is exactly what we needed. Clean, fast, defensible.”
“We evaluated three tools before NASHRA. Nothing else was built to our regulatory standards. The JFDA alignment was the deciding factor — plus it's the only platform our RA team actually wants to use.”
Ready to transform your regulatory workflow?
Your next submission is either 5 days away or half a day away. The difference is NASHRA.
No credit card required · Cancel anytime · JFDA-compliant from day one