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

Empowering Drug Registration with Digital, Integrated, and Intelligent Solutions

Reduce Costs. Improve Compliance. Accelerate Submissions.

Experts in Pharmaceutical Drug Registration

Driving Digital Transformation

Jinzhiqiao Pharmaceutical Technology

Your Global Partner in eCTD & Digital Drug Registration

Product Introduction

Drug Registration Document Management Subsystem

A secure, compliant, and efficient platform for managing regulatory documents.

MLPS Level 3 security, centralized storage, and intelligent workflows ensure fast access, full traceability, and regulatory compliance.

With automation, APIs, AI-assisted writing, and multilingual support, we help teams create and update documents faster and smarter.

Electronic Submission Subsystem

• Continuous support for TCM electronic submissions with full regulatory compliance

• Intelligent baseline sequence generation for faster, standardized submissions

eCTD Submission Subsystem

Built for global eCTD submissions, the platform fully supports the latest eCTD v3.2.2 and v4.0 standards, enabling smooth transitions and seamless upgrades.

Deeply integrated with project management, it delivers unified control across the entire eCTD lifecycle. Automated baseline creation and multi-dimensional content visualization streamline workflows, boost efficiency, and strengthen risk management.

More Than Software — Your Partner in Regulatory Success

• eCTD Preparation & Publishing– From source documents to compliant submissions

• Regulatory Consulting– Strategy, gap analysis, and regulatory planning

• Regulatory Translation (Chinese ↔ English)– Accurate, compliant, and industry-specialized

Delivery Models

SaaS (B/S Architecture)

Cloud-based, ready to use out of the box. No local installation, no maintenance burden.

Private Deployment

Deployed on on-premises servers or private cloud. Supports intranet access and meets strict data security and confidentiality requirements.

Customized Development

Tailored to your workflows and regulatory scenarios. Flexible extensions and bespoke functions to match your exact needs.

Source Code Delivery

Full source code provided for deep customization, secondary development, and long-term independent evolution.