US (United State) eCTD Suite
eCTD Global has robust and fully compliant eCTD solution software for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry thought the globe.
eCTD Global support all major eCTD accepting countries and for US (United State) dossier/submissions, US (United State) eCTD Suite is fully compliant with;
- US Module 1 Specification, version 1.3 (DTD 2.01)
- US Module 1 Specification, version 2.3 / version 2.4 (draft) (DTD 3.3)
- US eCTD Validation Criteria, version 3.8 (draft)
- ICH eCTD Specification, version 3.2.2
- ICH Study Tagging File (STF), version 2.6.1
- ICH M4 Organization of the CTD, October 2017
- US eCTD Technical Conformance Guide, version 1.3
- US PDF Specification, version 4.1
- US File Format Specification, version 3.0
- US Transmission Specifications, version 1.8
- US Study Data Technical Conformance Guide, version 4.2.1
- US Providing Regulatory Submissions in Electronic Format, Revision 6
EU (European Union) eCTD Suite
eCTD Global has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major eCTD accepting countries and for EU (European Union) dossier/submissions, EU (European Union) eCTD Suite is fully compliant with;
- EU Module 1 Specification, version 3.0.3 (DTD 3.0.1)
- EU eCTD Validation Criteria, version 7.1
- ICH eCTD Specification, version 3.2.2
CA (Canada) eCTD Suite
eCTD Global has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major eCTD accepting countries and for CA (Canada) dossier/submissions, CA (Canada) eCTD Suite is fully compliant with;
- CA Module 1 Specification, version 2.2 (DTD 2.2)
- CA Preparation of Drug Regulatory Activities in the eCTD Format-2015
- CA eCTD Validation Criteria, version 4.4
- ICH eCTD Specification, version 3.2.2
GCC (Gulf) eCTD Suite
eCTD Global has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major eCTD accepting countries and for GCC (Gulf) dossier/submissions, GCC (Gulf) eCTD Suite is fully compliant with;
- GCC Module 1 Specification, version 1.5 (DTD 1.1)
- GCC eCTD Validation Criteria, version 1.4
- ICH eCTD Specification, version 3.2.2
CH (Swiss) eCTD Suite
eCTD Global has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major eCTD accepting countries and for CH (Swiss) dossier/submissions, CH (Swiss) eCTD Suite is fully compliant with;
- CH Module 1 Specification, version 1.3 (DTD 1.3) – Valid till June 30, 2019
- CH Module 1 Specification, version 1.4 (DTD 1.4) – Must from July 01, 2019
- CH eCTD Validation Criteria, version 1.3 – Valid till June 30, 2019
- CH eCTD Validation Criteria, version 1.4 – Must from July 01, 2019
- ICH eCTD Specification, version 3.2.2
ZA-MCC-SAHPRA (South Africa) eCTD Suite
eCTD Global has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major eCTD accepting countries and for ZA-MCC (South Africa) dossier/submissions, ZA-MCC (SAHPRA) eCTD Suite is fully compliant with;
- ZA-MCC-SAHPARA Module 1 Specification, version 2.1 (DTD 2.1)
- ZA-MCC-SAHPARA eCTD Validation Criteria, version 2.1
- ICH eCTD Specification, version 3.2.2
AU (Australia) eCTD Suite
eCTD Global has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major eCTD accepting countries and for AU (Australia) dossier/submissions, AU (Australia) eCTD Suite is fully compliant with;
- AU Module 1 Specification, version 3.1 (DTD 3.1)
- AU eCTD Validation Criteria, version 3.1
- ICH eCTD Specification, version 3.2.2
eCTD Global has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major eCTD accepting countries and for JO (Jordan) dossier/submissions, JO (Jordan) eCTD Suite is fully compliant with;
- JO Module 1 Specification, version 1.0.2 (DTD 1.0)
- JO eCTD Validation Criteria, version 1.0
- ICH eCTD Specification, version 3.2.2
TH (Thailand) eCTD Suite
eCTD Global has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major eCTD accepting countries and for TH (Thailand) dossier/submissions, TH (Thailand) eCTD Suite is fully compliant with;
- TH Module 1 Specification, version 1.0 (DTD 1.0)
- TH eCTD Validation Criteria, version 1.0
- ICH eCTD Specification, version 3.2.2
eCTD Global Suite
Submission Management;
- Data/documents collection through DMS Repository
- Project micro-management with gap analysis
- Prepare & share eCTD checklist with Regulatory Operation/eCTD Publishing team
- Track and maintain submissions timelines through Global Submission Schedule (GSS)
- Archival of Dossier and Acknowledgement in in-built repository
Document Level Publishing (DLP);
- Word to PDF conversion/formation
- Insert, replace, edit, delete, extract, split and OCR pages
- Bookmarking, intra & inter document hyperlinking
- Toc generation, page numbering with header and footer
- Robust PDF properties correction features
Submission Level Publishing (SLP);
- Country-wise pre-defined eCTD template, Regional & ICH attributes
- Assign docs to eCTD Global Suite with life-cycle management
- Generate STF file tag element, datasets, CSR and CRF easily
- Pre-XML generation validation for PDF and other errors/warnings
- Validated XML output with in-built XML review capabilities
- Pre-defined Tracking Table generation in PDF format for DCP and MRP
eCTD Global Suite Features
Effective Dashboard
Get applications/submissions information on one click
Bridge between RA and RO
Both teams get email notification for all regulatory activities
Import Legacy Dossier
Quick import of legacy Dossier and maintain life-cycle
Hybrid Dossier Creation
Easily hybrid/clone application/sequence/document
Report Generation
Generate multiple types of reports on one click
Manage Applications
Ensure country-wise application access and doc management
Add, Edit, Delete Dossier
User can add, edit and delete application/sequence
Pre-define eCTD Template
Ensure agency acceptable pre-define eCTD template
Auto Title and Doc Name
Ensure correct auto Leaf Title and Doc Name
Create / Correct B&L
In-built capability to create and correct bookmark & hyperlink
Fit-n-Finish Validation
Ensure pre-XML generation validation
Build EU Tracking Table
In-built capability to generate tracking table in XML output
Retain/Convert File Format
Allow to retain default file format or convert into PDF
No XML and IT Knowledge
Ensure no XML Knowledge and IT infrastructure required
Auto Attribute Inheriting
Ensure to inherit Regional & ICH attributes from past sequences
XML Review
Allow to review of XML within eCTD Suite
Own Cloud for Dossier
Client-wise dedicated secured cloud for all applications
US STF Management
Easily create and maintain life-cycle for STF
Working Document in Tree
Allow to add working document in eCTD Tree
Fulfil Compliance
FDA 21 CFR part 11 & EU Annex 11 compliance with audit trail
eCTD Checklist Creation
Allow to create eCTD checklist for doc name, leaf title, life-cycle
RTR/RTF Validation
Ensure the RTR/RTF validation before XML generation
Acknowledgement Repository
Maintain repository for agency acknowledgment
Global Submission Schedule
System remind user for all upcoming planned submissions