Highthink eCTD Filing System

Introduction of the Highthink eCTD Filing System

Highthink eCTD is an eCTD submission system that integrates an eCTD format publisher, validator, editor, and lifecycle manager. It effectively shortens the preparation cycle for pharmaceutical companies' submission documents and improves submission efficiency. It supports submissions for regions including China, the United States, the European Union, Australia, and Canada. With fully independent intellectual property rights, it provides a comprehensive solution for pharmaceutical companies' registration and submission processes.

The system is developed by a unique team of experts from both home and abroad, including interdisciplinary professionals such as IT experts, programming teams, big data experts, data management experts, statistical experts, and specialists in GMP-GLP-GCP-ICH regulations. The team also includes former evaluators from domestic and international drug regulatory agencies who are well-versed in the entire process of API and pharmaceutical product development and market launch, along with CMC experts, toxicological safety assessment experts, and clinical experts. This team has an in-depth understanding of every code, function, module, step of validation, release, submission, process, and user issue within the Highthink eCTD system, ensuring customer peace of mind.

Version of the Highthink eCTD Filing System

Highthink eCTD Filing System includes three versions: Professional, Enterprise, and Expert. Each version is fully integrated with the functional requirements of numerous domestic and international clients and multiple drug regulatory agencies, and features a user-friendly interface in both Chinese and English, which greatly enhances the quality and efficiency of drug submissions.

• Professional Edition: Simple and economical, suitable for small and medium-sized pharmaceutical companies with infrequent annual submissions.
• Enterprise Edition: Offers both public and private cloud deployment options, allows team operations, and supports multiple people editing and publishing multiple projects simultaneously.
• Expert Edition: Both software and hardware are installed on a computer with an encryption lock, so you can start editing eCTD files directly.

Advantages of the Highthink eCTD Filing System

Highthink eCTD system has the following advantages:

Convenient and Quick

• Bilingual interface in both Chinese and English
• Clean and simple user interface
• Easy to operate with a strong interactive experience

Secure and Efficient

• Secure and independent storage server
• Comprehensive user permission settings and audit trail
• High-speed file processing, supports multi-user concurrency

Powerful Features

• Fully independent intellectual property rights
• Fast version updates

Professional Team

• Professional localized software development team

If you need help or have a question, please feel free to contact us for more details.