金智桥医药科技有限公司-致力于为国内外制药企业提供高质量的药品注册数字化解决方案

Digitalization、Informatization、Intelligentization

Streamline Drug Registration: Save Time, Effort and Resources

Specialized in Drug Registration within the Pharmaceutical Industry

Drive Industry Digital Transformation

Jinzhiqiao Pharmaceutical Technology

Your Expert in Drug Registration Digitalization

Product Introduction

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.

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.

About Us

We are steadfast in our commitment to innovation and expertise, serving the pharmaceutical industry with a focus on digital transformation in drug registration. Leveraging our extensive experience, we offer high-quality digital solutions to pharmaceutical companies worldwide. We keep abreast of global regulatory changes to ensure our offerings remain at the industry's forefront. Our proprietary drug registration management system adeptly addresses the practical challenges of electronic submissions, aiding clients in navigating drug registration processes, mitigating compliance risks, and enhancing efficiency.