CTD/Paper publishing & submission
KnowledgeNET’s CTD software is an engine, from which you can manage the documents in various formats (.doc, .pdf, .xml, .xpt, .xls and others) and also merge separate documents in one documents by one click. Single platform to manage, register, review, archive, publish CTD/paper dossier.
Nowadays, many pharma companies are interested in registration of drug product in various non-regulatory countries like ASEAN region, African region, CIS region, LATAM region and in many more region where the approval process in not tough.
This Document Management System (DMS) helps you to manage all the documents (confidential or non-confidential) at one place easily by high level security.
Our system have more than 80 CTD or ACTD structure of various countries from where you can easily create, publish and manipulated all the documents for regulatory submission.
CTD structure of various region as per latest regulatory guidelines of various country for drug registration
- ASEAN Region (ACTD Format): Malaysia, Singapore, Thailand, Vietnam, Cambodia, Myanmar, Philippines, Sri-Lanka and Hong-Kong etc.
- African Region (CTD Format): Nigeria, Kenya, South Africa, Zimbabwe, Tanzania, Ethiopia, Namibia and Mauritius etc.
- CIS (CTD Format): Moldova, Russia, Ukraine, Georgia, Kazakhstan, Uzbekistan etc.
- CTD Format: WHO and India etc.
- LATAM Region: Mexico, Panama, Venezuela, Chile, Costa-Rica, Dominican Republic and Jamaica etc.
- Various country specific CTD Format
CTD Submission & Document Management System Features
| Automatic TOC generation | System generate Table of Content (TOC) in each and every file with hyperlinking |
| Bookmark generation | System generate bookmark hierarchy as per the table of content (ToC) |
| Header & Footer generation | System generate the header (product name, applicant name, logo & section details) & footer (version no. & page no.) |
| Title page creation | System automatically create standard title page for each section |
| Shrink scan files | System shrink the scan file as per requirement with quality for header, footer management (scan file with or without header footer) |
| Paper CTD to electronic | By using KnowledgeNET, you can change your paper submission to Electronic means switching from Paper to eDMS submission |
| Regulatory compliance | System is fully 21 CFR part 11 (Electronic records and Signature) compliance |
Other dossier submission key features click here