eCTD, CTD, NeeS, Paper Regulatory submissions - KnowledgeNET

eCTD publishing software for regulatory submissions, KnowledgeNET, is a powerful, feature-packed document management solution that does virtually everything from storing to organising to managing the eCTD documents quickly, efficiently, reliably and above all, securely.

It has easy-to-use user interface which supports multiple regional templates like Canada, US and EU and also provides quick and intuitive construction of complex electronic submission set.

It also supports NeeS and paper based-CTD submission henceforth tackling with countries not yet started accepting the electronic submissions.

eCTD software solution helps MAHs to create, update, store and publish the  dossier  and manage, compile, review, register and archive eCTD submission.

Also the in-built validator ensures the compiled dossier generated is compliant with ICH standards (M2 to M5) and regional standards (M1).

Salient Features:

• eCTD submission software is Web based, easy to use intuitive interface
• Follows standards of ICH granularity M4 and M8 documents for CTD and eCTD respectively
• Fully compliant to 21CFR Part 11 electronic submission guideline
• Scalable high performance system with advanced technology
• Managing, Registering, Reviewing, Archiving and Publishing eCTD submission
• Generate MD5 check sum, 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, MRP, National and Centralised procedure submission types for EU Agency and ANDA, NDA, IND application types for US Agency
• Creation of separate internal and external submission sequence number to manage revised eCTD submission(s)
• Standard regional specific structures are inbuilt within the solution (i.e., US FDA, UK MHRA, EMEA, etc.) which can be inherited to multiple projects
• Lifecycle management easily maintained and at a glance difference in original and revised sequence can be identified with the operation type’s new/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 requirements

 

Modules:

• Master module :
• EU, US, other country template structure selection
• User Creation
• Region, Client entry, Attribute value addition
• Notice Management

• Project Creation
• File uploading
• Send files and comments
• Document stage management
• Reference document upload
• Submission
• Submission details entry
• Publishing
• Published eCTD dossier tracker
• Reports
• Doc summary
• Pending work status
• Project snapshot
• Search
• Criteria of time line, content
• Project level search