Output of this major scope validator are 3 Excel files: eCTD_XML_Report.xlsx - contains the relevant file output paths from the index and regional .xmls FilePaths.xlsx - contains the relevant file ...

The new offerings will leverage and complement the inherent strengths of ViewPoint, Octagon's Process Management Solution and extends the current functionality to address critical eCTD activities, ...

世界初のeCTD v4.0正式導入国・日本がグローバル移行をリード Freyr、東京で無料ワークショップを開催 Freyr Solutionsが、日本の製薬業界関係者向けに ...

The eCTD specifications define multiple requirements for the packaging and creation of submissions using XML files and lead to expedited regulatory life cycles as well as a reduction in the burden of ...

From January 2010, the eCTD (electronic Common Technical Document) format became compulsory for all electronic-only submissions via the Centralized Procedure. A recent EU survey revealed that 28% of ...

日本は、世界で初めてeCTD v4.0を正式導入する国として、グローバル規制の進化を牽引しています。これは、規制業務に携わる専門家にとって ...

This Web-based eCTD viewing solution includes support for all recent eCTD specifications and guidelines published by ICH, FDA, EMEA (including the most recent v1.2 specifications), Japan, Health ...