- About us -
Suzhou Collietech Information Technology Co.,Ltd is the first independent eCTD-related software and service provider in China. Collie eCTD software series independently developed by Collietech consist of several components and have received a number of patents, of which Collie eCTD Publisher is the first and only self-developed eCTD publish software in China that has passed validation of FDA and EDQM. Currently the series have been applied by several dozen domestic and foreign pharmaceutical companies, consulting companies, and a large number of eCTD registration specialists. All of registration submissions published by Collietech eCTD software have passed validation at the first attempt. Collietech takes opportunity of implementation of eCTD in China and makes every effort to establish most professional information technology and service provider of life science area in China.
- Product Introduction -
Safety Compliance Reliability High Efficiency No data breach risk
eCTD Pdf Assistant
As the first independent pdf file modifier for regulatory submission dossier, this mini software could perform massive validation and automatic modification to PDF files for submission, including correction of version, bookmarks, hyperlinks, fonds, navigate bookmarks, pages, annotations and amplification according to FDA and EU specifications respectively. It not only reduces the workload, but also considerably enhanced the efficiency of the registration unit for pharmaceutical industry.
eCTD Pdf Submission
Collie Es (Electronic Submission Management System) could support centralized repository, multi-dimensional indexing, fast positioning and extraction of regulatory documents in diversified formats according to multiple roles with different functionalities, and will make it easier for the team to record regulatory registration and application activities, to track the progress of registrations and applications, and to schedule upcoming submission tasks and commitment in advance.
eCTD Pdf Writer
Collie Ew (eCTD Word Plugin) will brought in abundant templates for files of different purposes. With functions of massive modification of PDF specifications, zoom level, hyperlinks, bookmarks and Table of Contents etc, it greatly improves the work efficiency of the regulatory editors.
- Service Mode -
Purchase complete software authorization + annual maintenance cost.
Company provides fundamental documents and entrusts eCTD generation and publication to Collietech.
Provide customized system development service for pharmaceutical companies with informatization demand.
Welcome Tryout : Collie eCTD Publisher
The only completely independent eCTD publishing software passing FDA and EU registration in China
- Process -
- Users and Partners -