EU (European Union) NeeS Suite
eCTD Global has robust and fully compliant NeeS software/solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global support all major NeeS accepting countries and for EU (European Union) dossier/submissions, EU (European Union) NeeS Suite is fully compliant with;
- EU NeeS Module 1 Specification, version 4.0
EU NeeS Validation Criteria, version 4.3
GCC (Gulf) NeeS Suite
eCTD Global has robust and fully compliant NeeS software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major NeeS accepting countries and for GCC (Gulf) dossier/submissions, GCC (Gulf) NeeS Suite is fully compliant with;
- GCC NeeS Module 1 Specification, version 1.2/ version 1.5
GCC NeeS Validation Criteria, version 1.2/ version 1.4
AU (Australia)/NZ (New Zealand) NeeS Suite
eCTD Global has robust and fully compliant NeeS software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major NeeS accepting countries and for AU (Australia) dossier/submissions, AU (Australia) NeeS Suite is fully compliant with;
- AU/NZ NeeS Module 1 Specification, version 2.0
AU/NZ NeeS Validation Criteria, version 2.0
Bosnia and Herzegovina NeeS Suite
eCTD Global has robust and fully compliant NeeS software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major NeeS accepting countries and for ALMBiH dossier/submissions, ALMBiH (Bosnia and Herzegovina) NeeS Suite is fully compliant with;
- ALMBiH NeeS Module 1 Specification, version 1.0
ALMBiH NeeS Validation Criteria, version 1.0
EU VNeeS Suite
eCTD Global has robust and fully compliant VNeeS software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
eCTD Global solutions support all major VNeeS accepting countries and for EU (European Union) dossier/submissions, EU (European Union) VNeeS Suite is fully compliant with;
- EU VNeeS eSubmission for a Veterinary Medicinal Product, version 2.6
EU VNeeS Validation Criteria, version 2.6
NeeS Suite
Submission Management;
- Data/documents collection through DMS Repository
- Project micro-management with gap analysis
- Prepare & share NeeS 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
NeeS Level Publishing (SLP);
- Country-wise pre-defined NeeS template
- Assign docs to NeeS Suite with robust PDF processing
- Generate CTD ToC and Module-wise ToC
- Pre-ToC/file-folder generation validation for PDF and other errors/warnings
- Validated NeeS ToC/file-folder output with in-built ToC Backbone review capabilities
NeeS 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