E-PIL Project
We convert, manage, and secure ePILs with cutting-edge AI and compliance-driven workflows.
Our Creative Workflow
Our NASHRA V2.0 Software is built upon a series of stages that guarantee the transformation of your Pharmaceutical Leaflets is fully compliant with your legal local FDA regulations and standards that follow the FHIR HL7 requirements.
1. Discovery
We carefully analyze your leaflet’s format and type (PIL, SmPC, etc.) while assessing page count, layout, and regulatory structure. At this stage, we identify artifacts to preserve or remove, check for OCR needs (image-based or Arabic text), and determine if splitting is required for bilingual files.
2. Conversion
Our AI-powered engine restructures your leaflets into standardized digital ePIL formats. This process is structured and built with the help of our pharmaceutical regulatory team who ensures accurate formatting, semantic clarity, and compliance with HL7 regulations
3. Validation
Each ePIL is carefully audited to confirm content accuracy, completeness, and compliance with regulatory standards. We verify context, language consistency, and ensure nothing is lost or misrepresented in conversion.
4. Approval
The regulatory project team lead meticulously reviews the ePIL to ensure all content, context, and meta-leaflet parameters are accurate. This includes verifying organizational details, medicinal data, and overall compliance before submission.
5. Submission
Each batch is prepared to include the original leaflet, the validated XML approved by the official FDA tool, a digital hashing certificate to ensure data integrity, a detailed transformation report, and secure archiving for future reference.
Elevating Digital ePIL Conversion Worldwide
Reasons To Partner With Us
Trusted Regulatory Compliance
Verified processes and regulatory oversight guarantee your leaflets are accurate, compliant, and regulator-ready.
Long Term Partnership
We ensure every update and new version of your leaflet is handled with precision, securing a long-term partnership.
Future-Ready Technology
Our technology is continuously updated to meet the latest FDA, EMA, and JFDA validation tools and standards.
Elevating ePIL Conversion With Packed Features
Batch & Version Management System
AI Powered Pharmaceutical OCR Tool
Role-Based Workflow
Your Own Personal Workspace (SaaS Coming Soon)
You Provide The Leaflets
We Take Care Of The Rest
1. Request Quotation
Start your compliance journey with a tailored plan and benefit from our large batch discounts.
Submit Original Leaflets
Get Instant Quote with Batch Discounts
Finalize the Contract
2. Conversion
Our AI and compliance team preprocess, convert, and structure your leaflets into regulator-ready digital ePIL formats.
Analyze Document Layout & Artifacts
Generate HL7 FHIR-compliant XML files
Comprehensive Audit & Validation
3. Submission
We deliver validated XMLs, integrity certificates, detailed reports, and secure archival for long-term use.
Generate Official Hashing Certificates
Provide Detailed Conversion Reports
Submit the Digital Leaflets Securely
280+
Converted Leaflets
Proven performance backed by measurable results for over 280+ Converted Leaflet.
18+
High Value Partners
Trusted by industry leaders, validated by numbers.
100%
Client Satisfaction
Excellence measured in partnerships, precision, and satisfaction
Our Success Stories
We take pride in partnering with leading pharmaceutical companies and healthcare providers, supporting them in achieving seamless regulatory compliance. Their success reflects the strength and reliability of our solutions.
“NASHRA streamlined our leaflet submissions and eliminated compliance risks. The accuracy and attention to detail are unmatched”
"Their technology and regulatory expertise gave us complete confidence. What used to take weeks now takes days, with zero errors."
