Collietech

eCTD publisher integrates all functions of validation and reading and supports multinational submission. It is completely designed and developed according to practical conditions and using behaviors of Chinese company users.

eCTD validator is an independent eCTD validation software. It perfectly satisfies regulation requirements of drug administration authorities in different countries. Validation result is accurate, compliant, reliable and efficient.

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.

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.

Collie Er (eCTD Reader) enables your review of various eCTD life cycle units: product application number, sequence number, submission activities, etc.

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.