eCTD Global has robust and fully compliant pCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.
As a Pharma Industry expert, we are aware that most of the countries are slowly moving towards the paperless dossier/submission.
This change shows the transformation of the pharmaceutical industry to comply with regulatory requirements (submission in electronic format either in pCTD, in NeeS and/or in the eCTD format as per the health authority requirements) and to make avail drug products on time to the consumer.
eCTD Global support for dossier/submissions in non-regulated/semi-regulated/ROW countries i.e. ASEAN, CIS, AFRICAN, LATAM, MENA region, pCTD Suite is fully compliant with;
- Common Technical Document (CTD) Format
- ASEAN Common Technical Dossier (ACTD) Format
- Country Specific/Region Specific Format
pCTD Suite
Submission Management;
- Data/documents collection through DMS Repository
- Project micro-management with gap analysis
- Track and maintain submissions timelines through Global Submission Schedule (GSS)
- Archival of Dossier and Acknowledgement and Approval Letter in in-built repository
Document Level Publishing (DLP);
- Word to PDF conversion/formation
- Insert, replace, edit, delete, extract, split and OCR pages
- Auto Bookmarking and intra-document hyperlinking
- Toc generation, page numbering with header and footer
pCTD Level Publishing (SLP);
- Country-wise pre-defined pCTD template
- Assign docs to pCTD Suite with robust Volume Conversion
- Generate CTD ToC and Module-wise ToC with Section Page
- In-built CTD ToC/file-folder/single file creation with header & footer
pCTD 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