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What is “GLP”?

GLP, standing for “Good Laboratory Practice,” is a quality system concerned with the management of research laboratories and organizations and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.>

Biotoxtech is according to the certification authority, it is called a non-clinical study operating regulation(Food and Drug Administration) and a excellent laboratory operating regulation (National Environment Research ,RDA). Biotoxtech Co., Ltd. Is one of the largest private company that has been certificated GLP

GLP Certification

Regulatory agency Certification date Test
  • The most GLP certification on tests
  • The only institution with
    GLP certification in
    local tolerance test
  • The first approved CRO
    from US FDA GLP inspection
March 14, 2002
  • Single dose toxicity
  • Local toxicity
December 13, 2002
  • Repeated dose toxicity (excluding inhalation exposure pathway)
  • Reproductive & Development toxicity
  • Genetic toxicity
  • Immunetoxicity
  • Other immune toxicity
  • Other toxicity (Phototoxicity, Photosensitization)
  • Carcinogenicity Study
March 10, 2006
  • In vitro mouse lymphoma TK test in Genetic toxicity
October 22, 2008
  • Safety pharmacology
  • Local Tolerance Study
  • Immune toxicity Study (Natural killer cell activity assay)
October 18, 2011 Other internationally approved Study(In vitro 3T3 NRU 광독성시험
July 29, 2013
  • Skin sensitization
  • In vitro alternative testing methods (Local Lymph Node Assay: BrdU)
  • Safety pharmacology
  • In vitro safety pharmacology study(hERG Assay)
February 4, 2020
  • Other Test Field - Other internationally approved tests
    - Reconstructed Human Cornea-Like Epithelium (RhCE) Test Method For Identifying Chemicals Not Requiring
  • Classification And Labelling For Eye Irritation Or Serious Eye Damage
    - In vitro Skin Irritation: Reconstructed Human Epidermis Test Method
October 23, 2020
  • Toxicity Test Field other genetic toxicity
    - In vitro Mammalian Alkaline Comet Assay
March 25, 2022
  • Other Test Field - Other internationally approved tests
    - In Chemico Direct Peptide Reactivity Assay, DPRA)
    - Local Lymph Node Assay; Bromodeoxyuridine-Flow Cytometry; LLNA BrdU-FCM)
Regulatory agency Certification date Test
  • A leader in REACH
    (Registration, Evaluation,
    Authorisation and
    Restriction of Chemicals)
    in accordance with the
    experience in domestic and
    foreign studies with
    a large number of chemicals
May 3, 2002
  • Acute oral/Dermal Toxicity Study
  • Acute Skin Irritation & Corrosion Study
  • Acute Eye Irritation & Corrosion Study
January 8, 2003
  • Skin Sensitization Study
  • Sub-acute/Chronic Toxicology
  • Genetic Toxicology
  • Reproductive & Developmental Toxicology
  • Maternal Function Study
  • Teratogenicity Study
  • Carcinogenicity Study
June 23, 2017
  • Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA
July 20, 2018
  • In Vitro 3T3 NRU Phototoxicity Test
July 9, 2021
  • In Vitro Skin Irritation: Reconstructed Human Epidermis Test Methods,
  • In Vitro Eye Irritation or Serious Eye Damage: Reconstructed Human Cornea-like Epithelium (RhCE) Test Methods
January 13, 2023
  • In Vitro Skin Corrosion: Reconstructed Human Epidermis Test Methods,
  • In Vitro Membrane Barrier Test Method for Skin Corrosion
Regulatory agency Certification date Test
  • A leader in domestic GLP tests
    of pesticides in accordance
    with the various experiences of
    Japanese pesticide testing
October 13, 2003
  • Acute oral/Dermal Toxicity Study
  • Skin Irritation Test
  • Carcinogenicity
  • Eye Irritation Test
  • Skin Sensitization Test
  • Sub-acute Oral/Dermal Toxicology
  • Deformity Toxicology
  • AMES
  • Microbial Toxicity Test
December 22, 2003
  • Chronic Toxicology
  • Reproductive Toxicology
May 4, 2023
  • Skin Corrosion

Korea’s Leading CRO