1629 N. Dixie Avenue, Kentucky, 42701
eCTD Submissions
Qtes-eCTD's primary function is publishing/creation of eCTD submissions, supporting the lifecycle
reated and sorted under authority and agency, under purpose Applicant name. Easy to find and view.
Life cycle view option where all nodes in all submissions will struct under selected submission, in that case, the current sequence and all the previous sequence files will sort together.
General Features
Move files & directories (keep the structure of the selected directory) to the submission. .
Keep history for each time submissions are created (current submission will be compressed with date/time), this may set to move this history to a cloud as a backup plan.
Submission will not be deleted till all Admin users approve that (to control the job and avoid mistakes).
Once the submission is completed the user will lock this submission, so no one can update it till the submission is unlocked by All admin users2.
Once the submission is published related validation report and table of content TOC will generate as pdf files to give a summary of the current job2.
All human action will be restricted and managed by the system to avoid validation errors, there are common issues the Application will control
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Qtes-eCTD's primary function is publishing/creation of eCTD submissions, supporting the lifecycle
Qtes-eCTD is a standalone Windows desktop application. Qtes-eCTD does not require any specific server/ database installations. Qtes-eCTD is a native Windows application (requires run-time Microsoft .Net).
Qtes-eCTD is a suite of integrated eCTD software products for the creation, manipulation, validation, publishing, and viewing of regulatory documentation for electronic submission by pharmaceutical companies to regulatory authorities
Qtes-eCTD can be installed on any Windows (2007 and later) or server-based
Build and fill XML eCTD backbone including all required attributes (ID, Checksum, href …).
Archived compressed instance for current submission for each published compiled submission.
On-Spot validation during submission building.
Archived validation report will generate each time validation occurs
Compile submission as selected authority procedur.
Validate existing compiled or imporetd submissions with a PDF validation report
Publishing submission with generated Table of Content TOC as PDF file including Envelope and filled parts and nodes.
Restricted permissions, authorized users have the permission to add new submissions, and delete or unlock published submissions for updates will occur when all authorized users confirm.
Publish compiled submission to defined or selected path with validation report & TOC and archive compressed submission with DateTime name.
Publish is not allowed until submission is compiled and locked
PDF Hyperlink & Bookmarks Fixer and Create.
Pdf file splitter.
Pdf file compression.
Pdf files compare.
Fix Pdf file to meet Authority requirement.
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We offer a wide range of IT consulting services, including software development, cloud computing solutions, cybersecurity, IT infrastructure management, and digital transformation strategies tailored to your business needs.
Our IT consulting services help businesses improve efficiency, enhance security, reduce operational costs, and stay ahead of technology trends. We provide expert guidance to optimize your IT infrastructure and implement innovative solutions.
We offer a wide range of IT consulting services, including software development, cloud computing solutions, cybersecurity, IT infrastructure management, and digital transformation strategies tailored to your business needs.
Our IT consulting services help businesses improve efficiency, enhance security, reduce operational costs, and stay ahead of technology trends. We provide expert guidance to optimize your IT infrastructure and implement innovative solutions.
We offer a wide range of IT consulting services, including software development, cloud computing solutions, cybersecurity, IT infrastructure management, and digital transformation strategies tailored to your business needs.
Our IT consulting services help businesses improve efficiency, enhance security, reduce operational costs, and stay ahead of technology trends. We provide expert guidance to optimize your IT infrastructure and implement innovative solutions.
We offer a wide range of IT consulting services, including software development, cloud computing solutions, cybersecurity, IT infrastructure management, and digital transformation strategies tailored to your business needs.
Our IT consulting services help businesses improve efficiency, enhance security, reduce operational costs, and stay ahead of technology trends. We provide expert guidance to optimize your IT infrastructure and implement innovative solutions.
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Marketing Manger
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Product Designer
Absolutely fantastic experience! The team exceeded our expectations and delivered a solution that perfectly met our needs. Their attention to detail and commitment to quality is unmatched.
UI/UX Designer
Absolutely fantastic experience! The team exceeded our expectations and delivered a solution that perfectly met our needs. Their attention to detail and commitment to quality is unmatched.
Marketing Manger
Absolutely fantastic experience! The team exceeded our expectations and delivered a solution that perfectly met our needs. Their attention to detail and commitment to quality is unmatched.
Product Designer
Absolutely fantastic experience! The team exceeded our expectations and delivered a solution that perfectly met our needs. Their attention to detail and commitment to quality is unmatched.
Marketing Manger