Jinzhiqiao Drug Registration Management System
A fully integrated suite of solutions—from eCTD publishing to document and project management—designed to streamline collaboration, improve efficiency, and simplify the drug registration process.
A fully integrated suite of solutions—from eCTD publishing to document and project management—designed to streamline collaboration, improve efficiency, and simplify the drug registration process.
• Centralized Document Management – Fine-grained classification and access control.
• Intelligent Approval & Audit Trails – Full traceability across workflows.
• Compliant Archiving & Sealing – Meets regulatory requirements.
• CDE Server Mirroring – Ensures data consistency and verifiability.
• One-Click PDF Standardization – eCTD-ready formatting.
• Custom Interfaces & On-Site Support – Flexible integration and expert assistance.
• Collaborative Editing & AI Writing – Faster document creation.
• Multilingual Capability – Machine translation with expert review for global submissions
• Continuously synchronized with the latest Chinese drug regulatory regulations and technical requirements
• Deep integration with the document management platform, eliminating duplicate document preparation
• Automated assembly of submission materials, minimizing manual operations
• Standardized workflow design, improving submission efficiency and stability
• Support for high-frequency, multi-project parallel submission scenarios
• Full compatibility with eCTD v3.2.2 and v4.0 technical standards
• Support for smooth upgrades and seamless transitions, reducing system evolution costs
• Unified management for submissions to both domestic and international regulatory authorities
• Deep integration with project management, enabling full lifecycle control of submissions
• Automated baseline submissions, minimizing manual configuration efforts
• Structured management and visualized review of submission content
• Clear sequencing and traceable version control, reducing submission risks
• eCTD Publishing Services
• Drug Registration Consulting Services
• Regulatory Document Translation Services (Chinese ↔ English)
