info@ectdglobal.com
+91 6359 596 967

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

has in-built capabilities to perform;

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