A Ready-to-use, Cost Effective & Regulatory guidelines compliant software solution
To create and manage regulatory guidelines compliant and validated eCTD Submission has become very critical activity. Region-wise requirements are different and its really challenging to manage them while Submission Building, Validation & Correction Activity.
Software plays vital role to Create, View + review, Validate, Publish and Manage lifecycle of Submission. Easier and User-friendly interface tones down efforts of RA team in preparation, validation and correction activity.
Ready-to-use Enterprise Version for Countries as per Latest Guidance as mentioned below:
Updated with latest Regulatory Authorities requirements
Lightweight, very simple & User-Friendly Interface with minimum training required
Major Regulatory Market requirements are managed like United State, European Unions, Canada, South Africa, Jordon, Gulf Coorporation Council, Australia, Thailand, Switzerland, World Health Organization along with Rest Of the World and ASEAN countries.
Assured validated and compliant output.
Web-based Application – Start using with minimum Server and Client Machine requirements | No specialized software OR hardware is required.
Powered with Adobe PDF library to perform PDF properties related activities like correction and verification in the most standard way.
Manages Hyperlink, Bookmark activity in easier, faster way; Quick / Auto / Copy / Auto-correct features help to avoid redundant activities of Hyperlink in each and every submission.
User & Super-User Dashboard to present Submissions using Graphical Interface.
eCTD file names and Titles are managed as per the regulatory requirements.
Multi-user system which supports parallel working on same or different submissions with controlled access permissions.
Audit Trails for each and every activity in compliance with 21 CRF guidelines.
Secured View for External Users.
Migration / Import activity for third party Submissions.
