Web based dossier submission management suite
Flawless process to generate fully compliant and validated xml
Comprised of eCTD , NeeS and pCTD , eCTD viewer and eValidator software
Overview
eCTD Global Suite
Compusys Technology is an official partner of eCTDGlobal providing Regulatory Operations/Publishing services (eCTD and NeeS – eSubmission Management, Document Level Publishing, Submission Level Publishing) and solutions (robust and fully compliant eCTD solutions) for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry thought the globe.
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
Hybrid Dossier Creation
Easily hybrid/clone application/sequence/document
Bridge between RA and RO
Both teams get email notification for all regulatory activities
Report Generation
Generate multiple types of reports on one click
Import Legacy Dossier
Quick import of legacy Dossier and maintain life-cycle
Manage Applications
Ensure country-wise application access and doc management
Overview
NeeS 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
- 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 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
Add, Edit, Delete Dossier
User can add, edit and delete application/sequence
Create / Correct B&L
In-built capability to create and correct bookmark & hyperlink
Retain/Convert File Format
Allow to retain default file format or convert into PDF
XML Review
Allow to review of XML within eCTD Suite
Pre-define eCTD Template
Ensure agency acceptable pre-define eCTD template
Fit-n-Finish Validation
Ensure pre-XML generation validation
No XML and IT Knowledge
Ensure no XML Knowledge and IT infrastructure required
Own Cloud for Dossier
Client-wise dedicated secured cloud for all applications
Auto Title and Doc Name
Ensure correct auto Leaf Title and Doc Name
Build EU Tracking Table
In-built capability to generate tracking table in XML output
Auto Attribute Inheriting
Ensure to inherit Regional & ICH attributes from past sequences
US STF Management
Easily create and maintain life-cycle for STF
Overview
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
eCTD Global provides Regulatory Operations / Publishing Support to Submission Management, Document Level Publishing, Submission Level Publishing
-Pharmaceuticals, Biopharmaceuticals, CMO and CRO
1.) Document Level Publishing
- Team eCTD Global assist pharma / healthcare industry for Document Level Publishing i.e. PDF documents conversions (bookmarks, hyperlinks, ToC etc)
- Harmonized PDF conversion process in adherence to client’s internal standards and health authority requirements
- Pre-defined templates for pCTD and NeeS submissions for EU, GCC, Canada, Australia and ROW / emerging markets.
- Country- wise and client-wise dedicated Regulatory Operations professional (Document Level Publishers)
- Multi stage review by using effective quality review checklist for pre-publishing activities
- To track end to end document level publishing activities, we have project wise document tracker and change history documents and things needed to remind during PDF conversions
- Team eCTD Global assist in Study Report Level Publishing (SRLP) for Clinical Study Report (CSR) and Clinical Trial Authorisation (CTA) activities as per client internal standards and Agency reequipments
3.) Document Level Publishing
- Submission Level Publishing team assist clients in all type of eCTD submissions i.e. Pre-approval (Original Application and its Amendments) as well as Post-approval (Supplement / Variations and Reports) for all eCTD accepting countries
- Team eCTD Global assist pharma / healthcare industry for Submission Level Publishing i.e. submission creation, document uploading, STF creation, external linking, compilation, validation / verification and dispatch of submission to health authorities
- Country- wise and client-wise dedicated Regulatory Operations professional (Submission Level Publishers)
- NeeS format and paper format to eCTD format conversion (baseline submission)
- Multi stage review by using effective quality review checklist for post publishing and compilation activities
- To track end to end submission level publishing activities, we have project wise eCTD tracker, metadata creation form, life-cycle management and change history documents and things needed to remind during submission dispatch
2.) Submission Level Publishing
- Expert advice for Regulatory Operations planning / strategy / management like submission attributes, STF file tag, gap analysis, and life cycle operations, document tracking through eCTD checklist & document change history and eValidation troubleshooting with strict adherence to health authority requirements
- Qualified and experienced Regulatory operation professionals who provide end-to-end publishing support and services (timely and high-quality submissions) throughout the life-cycle of product without any eCTD related deficiency
- Team eCTD Global assist pharma / healthcare industry with all required standards of Regulatory Publishing i.e. tools (PDF toolbox, eCTD Software and eValidator), submission checklist (file naming, leaf title, life–cycle operation), quality review checklist (pre, intermediate and post compilation) etc.
- Team eCTD Global support pharma / healthcare industry to harmonize their electronic submission (eCTD, NeeS and pCTD) process
- To avoid delay in submission, constant project micro-management by team leads
- Own Regulatory Publishing training program for all electronic submissions (eCTD and NeeS) requirements
- Country-wise and client-wise, experienced and qualified team for end to end Regulatory Operations service i.e. document level (DLP) and submission level publishing (SLP)
- Adopted culture and ethics to maintain confidentiality of client information
- 24 x 7 client support (anytime and anywhere)
- Multi stage and Multi level verification and review using QC checklist by experts before submission handover to client
- Team of experts to handle last minute changes / updates in dossier
- RO team is constantly tracking and updating internal processes and website blog for regulatory requirement and guidelines
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