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Regulatory Information Management

Regulatory Information Management

The core of Samarind RMS is its regulatory information management (RIM) database. This has been carefully structured to allow you to accurately record and maintain all your medicinal product information throughout its lifecycle.

Wherever possible, information is shared and reused, so that data is entered once only and drop-down/multiple choice lists are used wherever possible. This makes information easier to enter and quicker to update, as well as significantly improving the quality and accuracy of the data.

The Samarind RMS application provides the security, flexibility and ease of use that your regulatory affairs team needs to meet its regulatory and commercial obligations.

  • At-a-glance visibility of all the products in your portfolio
  • A secure central repository of all your product licence documentation, from SmPCs and PILs to PSURs and business contacts
  • Sophisticated administrator-configurable role-based user permissions, for flexible security
  • Event tracking for drug and device licensing applications, registrations, notifications, variations, PSURs and renewals
  • Records of information about key partners e.g. API manufacturers and QC Testing sites
  • Time stamped historical audit of all previous submissions and variations
  • System-generated notifications and alerts by email at key stages
  • All data contained within the same SQL database for security, robustness and performance
  • Extremely flexible and user friendly search and reporting facilities

Reporting

One of the additional key advantages of Samarind RMS’s database structure is that it provides a powerful platform for both ad-hoc and management reporting, delivering accurate results from live data.

Currently there are a series of pre-formatted, standard reports and in addition, our unique query tools provide a comprehensive facility for producing ad-hoc reports (we call this our ‘search & show me’ facility). Additional reports can be built at any time, giving our users the opportunity and flexibility to analyse upcoming deadlines, licenses per country, product per manufacturer and much more.

Our roadmap includes enhancements to the presentation of this data, through creating a simpler dashboard style overview of management information.

Contact us for a demo now!