eCTD submission software, dossier document management system and regulatory submissions

KnowledgeNET: Our eCTD software for regulatory submissions is a powerful, feature-packed document management solution that does virtually everything from store to organise to share to manage your eCTD Documents quickly, efficiently, reliably and above all, securely. eCTD software solution helps Pharmaceuticals companies to create, update, store and publish the complete set of dossier documents and manage, compile, review, register and archive eCTD Submission to regulatory agencies like US FDA and UK MHRA. eCTD submission software also helps in copying the relevant portion of previous submission to avoid duplication of work.

Our Report for validation makes sure that the submission created by KnowledgeNET is compliant with ICH standards (M2 to M5) and regional standards (M1).

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Key Features:

• eCTD submission software is Web based, easy to use intuitive interface
• Follows standards of ICH for eCTD and compliance 21CFR Part 11 guidelines.
• Scalable high performance system with advanced technology
• Fully documented and regulatory compliance for ICH, US FDA and EU EMEA
• Managing, Registering, Reviewing, archiving and Publishing eCTD submission.
• Build the XML backbone and other eCTD components with transparent user interface
• Combined with necessary dossier document management system functionality to effectively manage eCTD document life cycle.
• Adaptable to various regional standards for regulatory submissions and supports DCP and MRP procedures for EU and ANDA submissions for US FDA
• Generate MD5 check sum.
• Creation of separate internal and external submission Sequence No to manage revised eCTD submission(s).
• Standard regional specific structures are inbuilt within the solution (i.e., US FDA, UK MHRA, EMEA, etc.). One can inherit the structure to multiple projects.
• At a glance view of difference in original and revised submission (i.e., What operation is perform at each node delete/append/replace).
• Facility of managing dossier in CTD format for non regulated Market (i.e., countries in South America, Africa, etc.).
• Efficiently handles STF (Study Tagging Files) as per US FDA

For details, visit KnowledgeNET...