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LexisNexis Life Sciences Solutions and ONIX expand strategic alliance to guide pharma customers to market faster Professionals in the life sciences industry rely on unique regulatory affairs expertise...
Horsham, Pa., USA – February 24, 2022 – In response to the needs expressed by medical device manufacturers for ways to effectively manage the product lifecycle from conception through regulatory clearance and post-market activities, LexisNexis Life Sciences Solutions, a leading provider of data management and analytics solutions for the life sciences industry, is building an alliance of world-class solution providers, a collective of regulatory experts delivering solutions and services who support manufacturers, distributors and related operations. Answering the call for innovation in quality management systems, LexisNexis Life Sciences has expanded its collaboration with Greenlight Guru, the pioneer of the only dedicated Medical Device Success Platform (MDSP), serving the specialized workflows of manufacturers. Current and prospective customers of both companies can leverage exclusive benefits as part of this new strategic alliance.
“Implementation of Unique Device Identification (UDI) product data within US FDA, EU EUDAMED, China NMPA, South Korea MFDS, and other health authority databases creates complexity for medical device manufacturers. SingleSource™ for Medical Devices, along with the quality management and regulatory expertise of Greenlight Guru helps manufacturers in implementing best practices. With world-class workflow solutions, QA/RA professionals around the world benefit from superior, end-to-end traceability and quality standards to streamline efficiency, reduce risk and meet the compliance requirements of local health authorities,” said Arshad Rahman, General Manager of the LexisNexis Life Sciences division.
“Greenlight Guru is pleased to have an industry-leading UDI submission answer to solve for this step in the regulatory process. LexisNexis Life Sciences is a core UDI submission provider for many manufacturers around the world, large and small. Our customers can benefit from their specialized understanding of regulatory submission requirements for medical device manufacturers,” said David DeRam, CEO of Greenlight Guru.
Medical device manufacturers and labelers are continually upgrading processes and preparing for multiple global health authority requirements. The complementary solutions and services between LexisNexis Life Sciences and Greenlight Guru offer critical efficiency gains in managing the product life cycle.
LexisNexis Life Sciences Solutions helps manufacturers and distributors of medical device and drug products achieve regulatory compliance and improved product data management. For more information, visit LexisNexis Life Sciences.
LexisNexis Legal & Professional® is a leading global provider of legal, regulatory, and business information and analytics that helps customers increase productivity, improve decision-making and outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 160 countries with 10,400 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.
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