Rimsys, a provider of Regulatory Information Management (RIM) software for the medtech industry, has announced a strategic partnership with Clarivate, a provider of information and insights to accelerate the pace of innovation.
The new partnership pairs Clarivate Cortellis Regulatory Intelligence with the Rimsys RIM Platform, creating a new and unique solution that allows medtech regulatory affairs professionals to access global regulatory information and harness it directly within automated workflows. The solution enables regulatory affairs professionals to access over 200,000 regulatory documents from more than 80 countries directly in the Rimsys platform and associate them at the individual product level to simplify market submissions and respond rapidly to regulatory changes.
James Gianoutsos, founder and president of Rimsys, said: “Today, regulatory affairs professionals spend nearly half their time looking for information, and what they find is often unreliable or poorly translated. Our Advanced Regulatory Intelligence gives them easy access to reliable information and allows them to build powerful automations around it.”
The Rimsys RIM Platform is a cloud-based software solution that is designed explicitly around medtech regulatory activities and processes. It provides an integrated data hub for all regulatory information and documents and helps regulatory affairs teams streamline and automate critical processes.
Rimsys Advanced Regulatory Intelligence allows medtech regulatory affairs teams to:
- Identify market entrance requirements and historical product approval data to inform regulatory strategy
- Associate relevant market regulations directly with product registrations and essential principles/GSPR tables
- Automate regulatory product and UDI submissions with digital authoring, approval workflows, and publishing
- Monitor changing laws, regulations, and guidance documents to identify affected products and avoid compliance issues.
Gavin Coney, VP, science group channels & alliances, Clarivate, said: “We are proud to partner with Rimsys to provide actionable and valuable regulatory information to teams looking to reduce compliance risks and seamlessly bring their products to market. Pairing the comprehensive regulatory information of Clarivate Cortellis Regulatory Intelligence with the integrated data hub of the Rimsys Platform will enable users to amalgamate data and insights directly into workflows.”