Samarind's regulatory management solutions offer a complete answer to lifecycle management, structured document storage and regulatory submission.
Samarind RMS (regulatory management software) is designed to manage the regulatory submissions process end-to-end, including all licence submission and variation documentation with our ICH compliant eCTD tools, automatic uploading of EVMPD data to the EMEA's pharmacovigilance website, Med Info for recording queries and adverse events, etc.
With a significant number of events per product each year, it is essential to meet all critical deadlines relating to your product portfolio; responses to LODs, licence reimbursements, continuity of marketing activities within the sunset clause, GMP inspections, etc.
Samarind RMS's system generates email notifications and alerts help you to maintain all communications with the respective national authorities, key stakeholders within your organisation and any supply chain partners, helping to ensure that all critical deadlines are met.
In addition to the operational benefits provided by Samarind RMS, there are immense security advantages to be gained because all of the critical data (including documents) is contained within a single database. The use of Microsoft® SQL Server® as the back-end to the application offers great scope in terms of security, functionality and reporting. For example, a single report about how many variations affecting a single product are currently pending across Europe might take several days to produce manually; with Samarind RMS it would take a matter of seconds.
Samarind RMS is available as two options: RMS for Windows and RMS On Demand.
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