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.
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