OUR Workflow
NASHRA provides a full suite of services to transform, validate, and deliver pharmaceutical leaflets in compliance with global regulatory standards.
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.
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
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.