August 10, 2022
UL Solutions has entered into a reseller arrangement with clinical research organization (CRO) Navitas Life Sciences to provide pharmaceutical, medical device and biotechnology companies with access to the ComplianceWire® learning management system (LMS) for regulatory compliance training.
Under the reseller partnership arrangement, Navitas Life Sciences will be an authorized distributor for ComplianceWire®, the industry-leading LMS designed for e-learning and training for life sciences organizations, in India. Compliant with the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 as well as the European Union’s EU Annex 11 validation requirements, ComplianceWire® is used extensively by regulatory authorities in the U.S., China, Brazil and India. Since 1999, the FDA has relied on ComplianceWire® to train more than 40,000 global, federal, state and local agency investigators.
Through a unique Cooperative Research and Development Agreement (CRADA) with the FDA, UL Solutions can offer the life sciences industry the same training used by the FDA with ComplianceWire®.
Proactive compliance training for life sciences companies across multiple markets
As many life science companies pursue global commercialization strategies, utilizing digital LMS tools to provide education and training to employees for regulatory compliance across markets has become imperative to realizing business goals.
“With regulatory requirements becoming more complex and global in scope, we believe that the reseller partnership with Navitas Life Sciences will provide life sciences companies with greater access to ComplianceWire® to help them meet compliance requirements of the U.S. FDA and other regulatory bodies worldwide in order to bring medical device and pharmaceutical products to market safely,” said Jim O’Keefe, Director and General Manager of ComplianceWire®.
LMS tools to support regulatory compliance
As a CRO, Navitas Life Sciences has developed a legacy of expertise in implementing systems and serving as advisors to life sciences organizations. The company provides tailored solutions based on industry best practices, including GxP-compliant solutions for regulatory and pharmacovigilance efforts for more than 250 active customers, driving accelerated compliance and helping them to deliver first-time-right submissions.
“Life science companies consider learning management as a function that is quintessential to providing deeper insight, higher operational efficiency and optimal regulatory compliance across the organization,” said Marty Boom, global head of regulatory and safety at Navitas Life Sciences. “Such organizations look for a robust learning management system implemented by a partner with rich experience and expertise in the life sciences domain. Navitas Life Sciences and UL Solutions fulfill this requirement, which is why we are delighted to enter into this reseller partnership.”