Regulatory operations play a vital role in ensuring that organizations can bring safe and effective life-enhancing products to market faster while ensuring compliance with global regulatory requirements.
Driven by scientific and technological innovation, increased globalization, and continuously evolving regulatory requirements; today’s regulatory professionals contend with a high volume of complex data which needs to be managed and exchanged effectively with internal departments and health authorities. Whether it’s managing expanding UDI requirements for medical devices, transitioning from the EU's MDD to MDR, the drive towards the global implementation for ISO IDMP, or meeting the challenges of new innovative Combination Products, organizations require specialized and integrated tools that enable real-time collaboration between regulatory teams.
Imagine having all your regulatory information in one place. Products, licenses, registrations, suppliers, dossiers, health authority interactions, and regulatory change management workflows all linked together within one system.
Samarind RMS offers all these capabilities and more in a purpose-built, data-driven RIM system that ensures compliance and optimizes regulatory operations.
Samarind RMS Features