Online eCTD
Submission
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Question / Instruction:
REGeCTD Online (Publish, FDA) - not for public use
REGeCTD for Windows Desktop ...
File
New CTD (WORD) Package...
Open CTD (WORD) Package...
New eCTD (PDF) Package...
Open eCTD (PDF) Package...
Add New eCTD Sequence...
Online eCTD Validation (FDA)...
Clone CTD (WORD) Package...
Clone eCTD (PDF) Package...
Close Working Package (Exit)
Edit
Cut
Copy
Paste
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US Regional
Version 2.01
Version 3.3
Remove eCTD Files...
Insert eCTD Files...
New CTD Section File...
Open CTD Section File...
Save CTD Section File
Send to WORD Doc...
Menu Options
English Menu
Chinese Menu
Write CTD
Quality (CMC) Report Management...
Non-Clinical Report Management...
Clinical Trial Report Management...
Manage (WORD) Automation Collectively
Build CTD Hyperlinks Bookmarks...
Assemble CTD Table of Contents...
Add CTD List of Tables and Figures...
Assign Cross Hyperlinks for PDFs...
Remove CTD Hyperlinks Bookmarks...
Render WORD Files to Submission PDFs...
Manage Submission Folder Structure...
Publish eCTD
Modify eCTD Submission Info...
Modify Applicant Info...
Synchronize eCTD File Structure
Check eCTD Folder File Naming
Change eCTD Leaf Titles...
Add Study Tagging Files...
Manage Leaf Elements Collectively
Manage Module 1 Leaf Elements...
Manage Modules 2-3 Leaf Elements...
Manage Modules 4-5 Leaf Elements...
Publish eCTD Submission
Validate eCTD Submission
Submit via Submissions Gateway...
Review CTD
Approach Issues by Regulatory Strategies...
Build Justifications via FDA Guidances...
Propose Solutions via FDA Precedents...
Review CTD Content (Quality)...
Review CTD Content (Non-Clinical)...
Review CTD Content (Clinical)...
Assist Biopharmaceutics (Biowaiver)
Calculate Bioequivalence (Crossover Design)
Calculate Bioequivalence (Parallel Design)
CTD Write and Review by Experts...
eCTD Review and Verify by Experts...
Document
Document Description
Save Document Description
Document (PDF) Manipulation
Covert WORD Files in Folder...
Build Bookmarks in Folder...
Make TOC by Bookmarks in Folder...
Remove Bookmarks in Folder...
View/Edit eCTD Bookmarks in Folder...
Assemble Hyperlinks in Folder...
Add TOC Hyperlinks in Folder...
Remove Hyperlinks in Folder...
View/Edit eCTD Hyperlinks in Folder...
Sequence
Sequence Description
Save Sequence Description
Switch Sequence...
Expand Folder Abbreviation...
Edit All Leaf Parameters
Sequence Overview...
View Leaf Properties (Sorting)...
View 'Append' Operation (Seq)...
View 'Replace' Operation (Seq)...
View 'Delete' Operation (Seq)...
Sequence Management...
Lifecycle
Application Description
Save Application Description
Lifecycle Listing...
Lifecycle Overview...
Assemble Lifecycle Current...
View Leaf Properties...
View 'Append' Operation...
View 'Replace' Operation...
View 'Delete' Operation...
Lifecycle Management...
Help
View Help
Show User PPT
Operation Flowchart
Contact Experts for Advice
About REGeCTD License...
Status Bar
(License: eCTD publishing for single pharmaceutical company)
REGeCTD.com
eCTD (Publish)
(REGeCTD version 2.3.8.4 for Web)
License for © REGeCTD
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