Regulatory operations within the generics industry face many challenges when it comes to managing, maintaining, and filing generic product information with global regulators. These challenges include ensuring compliance with new and existing regulations, overseeing all the forms, data and documents needed for successful submissions, as well as preserving the status of those global licenses all while keeping track of tight deadlines.

Historically, regulatory professionals within the generics community have not had access to software solutions designed to meet their specific needs. This resulted in organizations managing and tracking information across multiple spreadsheets and cross-referencing files in document management systems leading to a cumbersome, error-prone, complicated, and expensive process.

Until now, solutions available to regulatory professionals only addressed a small selection of regulatory functions. This resulted in tools that only supported a few industry needs or required large integration and maintenance investments to make them fit for purpose.



 

Your Single Place of Truth™ for Regulatory Information

 

 

Imagine having all your regulatory information in one place. Products, licenses, facilities, documents, and workflows all linked together within one platform. Samarind RMS, a purpose-built pharmaceutical RIM system, is that single place of truth to leverage your regulatory information into streamlined workflows that can provide insight into upcoming activities as well as past knowledge of activities to drive your organization forward.




Samarind RMS Features

  • A secure RIM system with automated alerts and comprehensive reporting functionality
  • Integrated electronic document management system (EDMS) with templates that can leverage regulatory data
  • Ability to connect to external document management systems such as Documentum™ and SharePoint™
  • eCTD, VNeeS and NeeS modules for dossier creation and maintenance
  • xEVMPD module for automated maintenance of data
  • IDMP compliant processes and workflows
  • Project management functionality linking projects and tasks to the appropriate products, submissions, licenses, variations, and facilities data

 


Key Benefits

  • Lowers cost of ownership
  • All key regulatory functions now together in one integrated place
  • Enables efficient tracking and management of large numbers of products, submissions, and licenses
  • Reduces the risk of missed regulatory activities and deadlines via alerts and notifications
  • Maximizes the potential earnings of your licenses

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Samarind RMS provides the most efficient, practical and cost-effective way to
manage all regulatory information in one place.

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