About Us
Extending our specialized domains in clinical trial analysis and maximizing business value.
Securing utmost reliability and scientific excellence through unparalleled infrastructure and precision analytics.
Providing an innovative and streamlined experience for sponsors and investigators.
Expanding the horizons of clinical bioanalysis, delivering reliable data and an enhanced research experience.
As a GCLP-certified laboratory, U2XLab offers analytical services optimized for each specific research objective and development stage. Backed by extensive experience and a team of highly skilled experts, we encompass a broad spectrum of clinical bioanalysis—including biomarkers, PK/PD, and immunogenicity, moving beyond South Korea, we are evolving into a trusted bioanalytical partner perfectly aligned with the global research landscape.
Beyond mere analytical execution, our focus lies in perfecting the quality of each clinical trials. Ensuring data reliability through our precision analytical infrastructure and systematic quality management system, we deliver a highly efficient and transparent operational experience—from sample collection to investigator communication—powered by our proprietary clinical management system, RVDS.
U2XLab remains committed to being a trusted global analytical partner, driving the success of all clinical trials together by continuously expanding our analytical capabilities, elevating quality standards, and innovating the sponsor experience.
Business Areas
As a GCLP-certified bioanalytical laboratory, we deliver precision analytical services essential for the entire development lifecycle of new drugs, biologics, and health functional foods.
Utilizing advanced platforms such as LC-MS/MS, ELISA, and Multiplex, we deliver core analyses including PK/PD, ADA, and biomarkers. Furthermore, our proprietary RVDS system supports real-time sample management and seamless result tracking. Furthermore, we provide rigorous safety and efficacy evaluation services to support the regulatory approval of health functional foods.
Evaluation Services
Providing clinical performance evaluation and human-derived materials testing services for In Vitro Diagnostic (IVD) medical devices through a strategic partnership with U2Labs.
Providing research samples and clinical performance evaluations essential for the development and regulatory approval of In Vitro Diagnostic (IVD) medical devices. Furthermore, we support the R&D and regulatory approval processes of medical device companies through diverse evaluation services, including human-derived materials testing, diagnostic accuracy evaluation, and sensitivity and specificity validation.
Delivering personalized healthcare services by leveraging NGS (Next-Generation Sequencing)-based gut microbiome and blood analysis technologies.
Through the comprehensive analysis of gut microbiome and health data, we provide personalized probiotic recommendations. Additionally, a tailored health functional food recommendation service driven by health check-up results is scheduled to be launched soon.