Biotoxtech Co., Ltd. was established on 23 August 2000 and is headquartered at 53 Yeongudanji-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, South Korea (28115). The company is led by CEO Jong-Koo Kang, employs approximately 250 staff, and carries capital of KRW 35 billion as of December 2023. Its website operates in Korean, English, and Japanese, reflecting a client base spanning South Korea, Japan, and international pharmaceutical markets.

The company’s distinguishing credential is its position as the domestic private-sector holder of the greatest number of GLP (Good Laboratory Practice) certifications in South Korea, issued by the Korean Ministry of Food and Drug Safety (MFDS), the National Institute of Environmental Research (NIER), and the Rural Development Administration (RDA) — reflecting broad regulatory coverage across pharmaceuticals, chemicals, and agrochemicals. Its facilities are also certified by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the US FDA, enabling it to generate preclinical safety data accepted by three major regulatory systems from a single site.

The company conducts approximately 800 experiments annually across pharmaceuticals, cosmetics, food, and chemicals, and operates an AAALAC-accredited animal facility with an active Institutional Animal Care and Use Committee (IACUC), demonstrating compliance with international standards for humane animal research. Biotoxtech is a trilingual, multinational-accessible CRO, with online consulting available for international clients.

Key Products and Services

Safety Evaluation Research

• General Toxicity Studies — single-dose and repeat-dose toxicity studies in rodent and non-rodent species, conducted under GLP to ICH and OECD guidelines; applicable to pharmaceuticals, biologics, food additives, cosmetic ingredients, and chemicals
• Local Toxicity Studies — local tolerance studies including skin sensitisation, irritation, and photosensitivity; applicable to topical and injectable formulations and medical devices
• Reproductive and Developmental Studies — fertility and early embryonic development, embryo-foetal development, and pre- and postnatal development studies under OECD and ICH S5 guidelines
• Genotoxicity Studies — in vitro and in vivo genotoxicity testing including bacterial reverse mutation (Ames), chromosomal aberration, and in vivo micronucleus assays under ICH S2 guidelines
• Immunotoxicity Studies — immunotoxicity assessment as required under ICH S8 and OECD 407, including lymphocyte immunophenotyping and functional immune assays
• Carcinogenicity Studies — long-term carcinogenicity studies in rodents under ICH S1 guidelines for pharmaceutical and chemical clients
• Safety Pharmacology — core battery and supplemental safety pharmacology studies assessing cardiovascular, CNS, and respiratory function under ICH S7A and S7B guidelines
• Ecotoxicology Studies — environmental toxicology studies for chemicals and agrochemicals under OECD guidelines, conducted under RDA and NIER GLP certification
• Histopathology and Clinical Pathology — in-house histopathology and clinical pathology services including haematology, clinical chemistry, urinalysis, and organ weight assessments; integrated within toxicology studies or available as standalone services
• Juvenile Animal Toxicity Studies — paediatric toxicology studies in juvenile animals, required by regulatory authorities for pharmaceuticals intended for use in children

Efficacy Evaluation Research

• Medicine — in vivo pharmacological efficacy evaluation across disease model systems for pharmaceutical drug candidates
• Food — efficacy evaluation of food ingredients and functional food products in appropriate in vitro and in vivo models
• Cosmetics — efficacy evaluation of cosmetic ingredients and formulations including anti-ageing, whitening, and moisturising endpoint assessments

Analysis Research

• PK/TK/ADME — pharmacokinetic, toxicokinetic, and absorption/distribution/metabolism/excretion studies in support of IND-enabling preclinical programmes
• Bioanalytical Method Development and Validation — development and validation of bioanalytical methods to FDA and EMA guidance standards, including HPLC, LC-MS/MS, and ligand binding assay approaches
• Bioanalysis — sample analysis for PK/TK studies, including measurement of drug concentrations in plasma, tissues, and other biological matrices

Consulting

• Business consulting for nonclinical trial planning — strategic advisory for sponsors designing preclinical programmes, selecting study types, and preparing regulatory submission packages

Biotoxtech occupies a well-established position in South Korea’s preclinical CRO sector, distinguished by the breadth of its GLP certifications — covering pharmaceuticals, chemicals, and agrochemicals across three South Korean regulatory bodies — and by dual regulatory recognition from the US FDA and Japan’s PMDA, which enables it to conduct IND-enabling toxicology studies accepted by the world’s three most significant drug regulatory systems from a single facility. This regulatory coverage is a material differentiator for international sponsors, particularly Japanese and US pharmaceutical companies seeking cost-competitive Asian preclinical CRO capacity that does not require re-validation or bridging studies for FDA or PMDA submissions. Its AAALAC accreditation and IACUC oversight meet international expectations for animal research ethics that are now routinely required by major pharmaceutical sponsor qualification programmes. The company’s approximately 800 annual experiments across four client industries — pharmaceuticals, cosmetics, food, and chemicals — and its 250-person workforce represent a mature, commercially active operation rather than a niche boutique, consistent with its self-description as having grown from a small CRO into a genuinely global operation over more than two decades.