We offer more than just basic document management services; our system includes multiple subsystems such as drug registration project management and intelligence subsystems. Our electronic and eCTD submission systems are closely aligned with regulatory changes, giving your submissions a head start. By seamlessly integrating with our document management system, we simplify document preparation, makes your submission simple and convenient.
Our Drug Registration Document Management Subsystem is a fortress of security, employing national level-3 protection to secure data and servers. It offers centralized, classified document storage for quick retrieval, an intelligent approval process, and comprehensive tracking and archiving. Synced with the CDE server, it ensures compliance and traceability. We also provide automated file repairs, custom interfaces, and on-site support for legacy issues. Our system simplifies multi-country drug registrations with machine translation and proofreading, and boosts document creation with collaborative editing and AI assistance.
Jinzhiqiao Electronic Submission Subsystem keeps pace with regulatory changes, ensuring your submissions a head start. It seamlessly integrates with our document management for automated document assembly, simplifying the process.
Our globally accessible eCTD submission system is designed to be compatible with the latest eCTD v3.2.2 and v4.0 technical standards, ensuring a smooth transition and technical upgrade. It integrates a project management module that oversees the entire eCTD submission process, guaranteeing a smooth conversion and a continuous submission flow. This integration enables automatic baseline submissions and offers a comprehensive view of the submission content, streamlining the entire submission process.
