- CEO
- Sang-Deuk Lee
- Full Time Employees
- 141
- Sector
- Commercial services
- Industry
- Miscellaneous commercial services
- Address
- Yongin-si South Korea
- IPO Date
- Mar 2, 2023
- Business
- BioInfra Co.,Ltd. is a South Korea-based contract research organization (CRO) that provides comprehensive bioanalytical, clinical trial management, and pharmaceutical testing services to domestic and global pharmaceutical and biotechnology enterprises. Founded in 2007 and headquartered in Yongin-si, Gyeonggi-do, South Korea, the company operates within the life sciences tools and services sector, serving clients developing novel therapeutics, incrementally modified drugs, biosimilars, and generic pharmaceuticals. The company's core service and product offerings include: bioequivalence (BE) study design, management, and bioanalysis for generic pharmaceuticals, an area where the company maintains a leading domestic market share; early- and late-stage clinical trial execution, encompassing Phase I first-in-human and clinical pharmacology studies, Phase II and Phase III therapeutic exploratory and confirmatory trials, and regulatory submission support; bioanalytical laboratory services, delivering pharmacokinetic (PK), pharmacodynamic (PD), toxicokinetic (TK), and biomarker quantification for small molecules, peptides, and biopharmaceuticals; advanced immunoassay and high-resolution liquid chromatography-tandem mass spectrometry (LC-MS/MS) analytical platforms, specifically configured for complex modalities such as antibody-drug conjugates (ADCs) and therapeutic proteins; certified pharmaceutical quality testing and inspection services authorized by the South Korean Ministry of Food and Drug Safety (MFDS), comprising commercial batch release testing for finished drug products, comparative dissolution testing, long-term and accelerated stability testing, and mutagenic and genotoxic impurity profiling; and automated sample preparation and laboratory information management solutions designed to maintain compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) standards. In recent strategic and operational developments, BioInfra has broadened its business scope from its historical foundation in bioequivalence and Phase I trials into full-service Phase II and III clinical operations and commercial quality control testing. Following its public listing on the KOSDAQ exchange (KRX: 199730), the company expanded its specialized Testing and Inspection Center to accommodate sterile injectable and oral solid dosage formulations. In September 2026, BioInfra acquired 100 percent of the outstanding shares of its analytical affiliate, UNInfra Co., Ltd., converting it into a wholly owned subsidiary to directly internalize and scale specialized genotoxic impurity testing capabilities, including nitrosamine and NDSRI analysis, and to streamline laboratory workflows ahead of an integrated corporate reorganization.