イーサ List of Products and Services

1. eCTD v3.2.2 to 4.0, all eCTD packages compliant with the specifications of regulatory authorities in various countries can be viewed. 2. All eCTD documents are centrally managed, allowing for smooth and real-time viewing, modification, review, approval, and sharing anytime and anywhere. 3. The comment feature enables information sharing on the same platform.

• others

eP2AS VAL verifies the PDF files converted from Word documents by the rendition tool for the following: 1. Requirements for PDFs and pages in the leaf file, bookmarks within the document, links within the document, inter-file consistency, font color, image resolution, etc. 2. It corrects the listed candidates for modification according to the established rules.

• others

We provide consulting services based on our expertise and technical support for customers who are struggling to prepare for the eCTD submission environment or who have concerns about their current eCTD submission environment and eCTD creation process. Please feel free to contact us if you have any requests. 【We address the following issues】 ■ Establishment of eCTD submission environment ■ Introduction of templates compatible with eCTD ■ QC tasks that do not pose problems for eCTD submissions ■ Publishing tasks (PDF conversion/application information provision) ■ eCTD creation tasks (XML/folder structure) *For more details, please download the PDF or contact us.

• Document Management System