Drug Dossier and Data Tracker
Sarjen, not only simplifies the submission process to the regulatory authorities but also understands the complex hassles that could arise before and after the submission of a dossier.
Assignments of project timeline, tracking pre- and post-submission details are tedious tasks for any establishment to manage. To manage data coming in from various sites from SPC/SMPC (Summary of Product Characteristics) label information to the Product Information required by QP (Quality Process), Regulatory department and Pharmacovigilance team changes the thought process of any establishment to transform from manual mode to the electronic mode.
Sarjen's Drug Dossier Tracking system helps you to manage PSUR dates, License renewal dates, Deficiency letters and variations supported with features such as reminders and pop-ups so that you don't miss out on critical issues during submission.
Salient Features:
- Assignments of project timelines
- Alerts on schedules, delays
- Track timelines pre- and post-submissions
- Reminder of actions on regulatory events such as PSUR dates, License renewals, Deficiency letters and variations
- Stores and shares license information, Drug label (SPC) information, Release site details
- Complete audit trail on activity actions
- Snapshot view of all projects’ tracking
- Track SPC label information, Site details (release, QC, API, FP) and other key product information required by QP, Regulatory department and Pharmacovigilance team
