- CEO
- Jong-Gu Kang
- Full Time Employees
- 241
- Sector
- Commercial services
- Industry
- Miscellaneous commercial services
- Address
- Cheongju-si South Korea
- IPO Date
- Sep 21, 2007
- Business
- Biotoxtech Co., Ltd. is a South Korea-based non-clinical contract research organization primarily engaged in providing safety, toxicity, efficacy, and analytical testing services for pharmaceuticals, biopharmaceuticals, medical devices, health functional foods, cosmetics, and agricultural chemicals. Founded in 2000 and headquartered in Cheongju-si, Chungcheongbuk-do, South Korea, the company operates under Good Laboratory Practice standards certified by the Korean Ministry of Food and Drug Safety, the Ministry of Environment, and the Rural Development Administration, maintaining full accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International.
The company offers a comprehensive portfolio of contract research services, including: general toxicity testing, comprising single-dose toxicity, repeated-dose toxicity, dose range finding, and maximum tolerated dose studies; genetic toxicity testing, encompassing bacterial reverse mutation assays, in vitro chromosomal aberration tests, in vitro micronucleus tests, and in vivo rodent bone marrow micronucleus assays; reproductive and developmental toxicity evaluations, covering fertility and early embryonic development, embryo-fetal development, and pre- and postnatal development studies; safety pharmacology testing, addressing core battery assessments for cardiovascular, central nervous system, and respiratory functions; carcinogenicity studies, including standard rodent bioassays and transgenic models; local tolerance and irritation testing, including ocular irritation, dermal irritation, skin sensitization, and phototoxicity evaluations; pharmacokinetic, pharmacodynamic, and toxicokinetic studies, featuring liquid chromatography-tandem mass spectrometry bioanalysis, metabolite profiling, bioequivalence testing, and absorption, distribution, metabolism, and excretion profiling; in vivo efficacy testing and disease model development across oncology, metabolic disorders, immunology, inflammation, and central nervous system indications; histopathology and toxicologic pathology services, including gross pathology, tissue processing, slide preparation, immunohistochemistry, and certified veterinary pathologist peer review; medical device biocompatibility testing in accordance with ISO 10993 standards; and environmental risk assessment and ecotoxicology testing complying with OECD guidelines for global chemical regulations.
Through its affiliated network and subsidiaries, including Keyprime Research Co., Ltd. and Biostandard Inc., the company extends its testing portfolio to include specialized non-human primate and large-animal research models as well as pharmaceutical formulation analysis. Biotoxtech caters to biopharmaceutical enterprises, chemical corporations, research institutes, and healthcare organizations across South Korea, North America, Europe, and the broader Asia-Pacific region.
In recent developments, Biotoxtech has expanded its advanced bioanalytical testing platforms to accommodate next-generation therapeutic modalities, introducing specialized biodistribution, pharmacokinetic, and safety profiling capabilities for cell and gene therapies, antibody-drug conjugates, and oligonucleotide therapeutics. The company has enhanced its large-animal testing capacity and modernized its automated vivarium infrastructure and electronic Good Laboratory Practice data management systems. Furthermore, Biotoxtech has formed strategic service alliances with emerging biotechnology developers and academic medical centers to deliver integrated translational research packages, while broadening its global regulatory consulting operations to support clients preparing Investigational New Drug and New Drug Application dossiers for submission to the U.S. Food and Drug Administration, the European Medicines Agency, and the Japan Pharmaceuticals and Medical Devices Agency.