Agati’s SubmitBot product addresses the pains and nuances involved in document publishing and regulatory submission packaging in the eCTD structure. It takes away the difficulties involved in document level publishing activity and automates the submission package creation by tremendously reducing the time to create the final package ready for submission to any regulatory agency.
Key Features of SubmitBot:
Supports multiple agencies including FDA, EU, CA, CH, SFDA, TGA, MCC, JP to create eCTD submissions
Valid eCTD submissions/sequences created by other tools can be imported into SubmitBot
Automatic PDF conversions, agency recommended PDF settings and In-Place PDF editing within the SubmitBot application
No dependency on other third-party tool for hyper-linking and book-marking
Comprehensive Study Tagging File (STF) creation and easy Life cycle Management (LCM)
Reduced time and effort through Library feature which help in reusing the common modules prepared for other agencies
In-built DMS (Document Management System) module for document life cycle management
Director, Clinical Data Services
Nishanth Nalachandrasekaran is our Director in Clinical Data Services unit and he has around 15 years of experience in the Clinical Research industry. In his current role, he leads a group of data analysts and programmers. Prior to joining us, Nishanth was leading the Biometrics business unit at Quartesian Clinical Research. Throughout his career, he has played various roles in different organizations and gained good exposure & understanding of cultural differences across different countries. He is also an active participant in industrial events in India like PhUSE SDE and ConSPIC. He holds a Master’s degree in Computer Applications and a Post Graduate Diploma in Human Resources Development.