The tracking of regulatory affairs activities throughout the product lifecycle is central to the Samarind RMS system. Building on the comprehensive ‘master data’ within the RMS database, the system provides full tracking facilities with automated alerts and notifications to help you meet every deadline.
- Plan your applications, variations and other activities from an early stage
- All regulatory submissions can be planned, tracked and monitored
- Track patent expiry dates, PSUR data lock points and country-specific milestones
- Automatic email notifications are send to the relevant people when key data changes, for example on marketing authorisation approval or receipt of PSUR response
- Scheduled, automatic email alerts remind interested users of upcoming deadlines and key milestones
- Project planning modules are also available
Samarind RMS now supports veterinary products too, including data relating to species, withdrawal period and dosage rates.