Introducing Samarind RMS
Samarind RMS is a configurable off-the-shelf (COTS) database software solution for regulatory affairs (RA) and pharmacovigilance (PV) professionals. The system provides a ‘single place of truth’ for all the regulatory and pharmacovigilance information relating to medicinal and medical device product life cycles, managing and streamlining the process of submitting that information to the relevant authorities and other stakeholders. Using Samarind RMS can significantly increase the efficiency and compliance of the teams involved, improve information quality and reduce the risks associated with trying to keep complex regulatory and pharmacovigilance data up-to-date.
In this section of the website you will find comprehensive information about the Samarind RMS product.
- The ‘single place of truth’ concept and why we call this “the smarter way” of handling your product information
- An overview of our Regulatory Information Management (RIM) solution, including planning, tracking and alerts
- XEVMPD – how and why we automate XEVMPD data maintenance and how we’ll migrate ISO IDMP
- eCTD and NeeS – fast, accurate and easy dossier creation
- EDMS – why our Electronic Document Management System (EDMS) is fully integrated into the Samarind RMS system and the advantages this brings
- Medical Devices – regulatory data management for devices – planning, tracking and alerts and automated Unique Device Identification (UDI) submission and maintenance
- Drug Safety – easy ICSR management and reporting with linkages back to the master product data in the RIM module
- Deployment options – on-premise, hosted or Cloud-based
For more information please get in touch using the details on our contact form.