Your Smart eLeaflet Hub.
NASHRA transforms raw pharmaceutical documents into structured, FHIR-compliant ePI bundles — the ultimate platform for eLeaflet and Regulatory Pharma Tech.
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.
Manage your XML modules visually.
Review, edit, and export your ePI content as structured XML. Complete traceability from source to submission-ready artifact.
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.
NeuroOCR
Vision-powered clinical document scanning. Converts image-only PDF pages and bilingual Arabic/Latin tables into digital text.
NeuroExtract
High-fidelity administrative entity extractor. Pulls product names, MAH metadata, and license records to bypass manual entry.
NeuroSect
Two-pass document structure analyzer. Maps raw text into hierarchical FHIR-compliant section structures with 100% data preservation.
NeuroMed
Clinical terminology mapper. Extracts active substances, strengths, excipients, and routes, matching them to FHIR reference sets.
NeuroChat
Context-aware editor co-pilot. Enables real-time, bilingual query-based updates and formatting corrections directly inside the editor.
NeuroTVT
Word-by-word text verification engine. Electronically audits draft XML content against raw source PDF files for clinical compliance.
NeuroAnalytics
Master 8-parallel audit coordinator. Conducts comprehensive, web-grounded validation checks for maximum safety and JFDA alignment.
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.
NASHRAcutourePILauthoringcyclefromthreeweekstounderfourdays.TheFHIRR5exportisflawlessandtheJFDAsubmissionwentthroughonthefirstpass.
Khalid Al-Rashid
Head of Regulatory Affairs
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