Drug Reg Doc Management Subsystem

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.

Electronic Submission Subsystem

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. For SaaS users, we offer a one-click disc burning service, facilitating the quick and efficient submission to regulatory agencies.

eCTD Submission System

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.

Product Solution

SaaS product with B/S architecture：

Accessed via browser, no local installation required. Uses enhanced level-3 protection scheme server. Suitable for rapid deployment and cloud management.

Private deployment：

Product can be deployed on customer's server, support intranet access for high-level confidentiality. Promise 2-year functional updates and 3-year quality maintenance.

Customized development：

Tailored to specific needs, we offer a high degree of customization services with quality updates for 2 years, expanding product functionality to meet personalized requirements.

Source Code Level Product Delivery：

For clients requiring in-depth customization and long-term independent development, we can provide product delivery at the source code level, accompanied by a long-term support plan that includes 3 years of functional updates and 5 years of quality updates.

Cooperation Partner