The collaboration of the leading providers of Unique Device Identification (UDI) for global health authorities and RIMS compliance platform, supports global medical device companies.
LexisNexis Legal & Professional today announced, that LexisNexis Reed Tech, provider of data management & analytic solutions for the life sciences industry, has expanded its collaboration with RegDesk, a provider of best-in-class Regulatory Information Management Systems Platform (RIMS). RegDesk offers a global submission management and regulatory intelligence platform powered by AI to provide an expedited way to prepare submissions and obtain insights into regulatory changes in over 120 countries. Current and prospective customers of both companies can effectively manage the increasing complexity of complying with ever-changing global regulations.
“RegDesk provides RIMS software that streamlines medical device registration and intelligence tracking for health authorities around the globe. Marrying the capabilities of RegDesk with the Unique Device Identification (UDI) submission expertise of LexisNexis Reed Tech, will help companies get to market faster while remaining compliant with regional health authority requirements,” said Arshad Rahman, General Manager of the LexisNexis Reed Tech Life Sciences division.
“With their deep experience in regulatory data submissions, Reed Tech leads the industry with machine-to-machine UDI services for medical device makers around the world, large and small. As a submitter of close to 34% of the annual electronic records submitted to the FDA GUDID database, their decades of experience have positioned them as an industry leader in the MedTech community. We look forward to offering the wealth of expertise and guidance provided by the Reed Tech team of technical specialists in understanding global regulatory submission requirements, particularly for EU EUDAMED, China NMPA, and South Korea MFDS,” said Priya Bhutani, Founder & CEO of RegDesk.
LexisNexis Reed Tech is expanding its collective of regulatory experts delivering solutions and services who support medical device and pharmaceutical manufacturers, distributors, and related operations. The obligations to regulators require experienced insights to get to market and stay compliant. The complementary services between LexisNexis Reed Tech and RegDesk meet the need to consolidate the regulatory approval process from the intelligence gathering phase to application building and continued requirements tracking once in market.
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