eCTD
Software - eCommon Technical Document - Regulatory eSubmissions
What
is eCTD - electronic common technical document?
Since
1990, ICH (International Conference on Harmonization)
has been working to create a standardize framework for
drug and biological product registration. An expert
working group within ICH is working on eCTD
specification, an electronic equivalent to paper CTD. An
eCTD is primarily a specification for interface between
the agency and the industry to enable the transfer of
regulatory information.
eCTD
Software
Our eCTD
software for regulatory submissions is a powerful, feature-packed document/knowledge management solution that does virtually everything from store to organize 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
submissions 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.
Free
eCTD
validator
Our
Report for validation makes sure that the submission
created by KnowledgeNET are compliant with ICH standards
(M2 to M5) and regional standards (M1). Since
eCTD standards and guide lines are under development and
review, validation mechanism of KnowledgeNET eCTD
software solution gives you alerts and warnings based on
selected set of parameters.
Key Features of eCTD Submission software Solution:
-
Manage, Register, Review and Archive the eCTD submission
-
User
friendly software with drag and drop facilities
simplifies eCTD preparation and provide
efficient mechanism to create, collect and compile
eCTD dossiers
-
Build the XML backbone and other eCTD components with transparent user interface
-
Modular system architecture to perform updates to the submission without disturbing the entire system
-
Adaptable to various regional standards and own standards can be defined and
practiced
-
Generate MD5 check
sum
-
Follows standards of ICH
(US FDA, UK MHRA) for eCTD and compliance 21CFR guidelines
-
Java used to provide platform independence and higher level of security
-
Capable
of handling FDA's Study Tagging Files (STF)
requirement and Europe's Product Information
Management (PIM) standards.
