Nonclinical CRO Business Unit

Introduction of the Nonclinical CRO
Business Unit

Service Introduction of the Nonclinical CRO
Business Unit

Certification Status

The only institution in the country with the highest number of items certified under GLP

Inspection agency	Ministry of Food and Drug Safety (MFDS)
Date of Initial accreditation	2002.08.12
Certification Status	Pharmaceuticals, foods, cosmetics, etc. Single-dose toxicity study (Excluding inhalation route) Repeated-dose toxicity study (Excluding inhalation route) Reproductive·developmental toxicity studies Fertility and early embryogenic development study Embryo-fetal developmental toxicity study Pre- and postnatal developmental toxicity study Genotoxicity test In vitro mammalian chromosome aberration test In vitro mammalian cell micronucleus test In vivo mammalian erythrocyte micronucleus test Other genotoxicity test in vitro mammalian cell gene mutation test (thymidine kinase gene) In vivo mammalian alkaline comet assay Antigenicity study Active systemic anaphylaxis study Passive cutaneous anaphylaxis study Skin sensitization study Carcinogenicity study Local toxicity study Skin irritation study Eye irritation study Local tolerance study Other toxicity test Photosensitization test Phototoxicity test Genotoxicity test Bacterial reverse mutation test Analytical study Analytical test during toxicokinetic study Other analysis study Safety pharmacology study Central nervous system safety pharmacology study Respiratory system safety pharmacology study Cardiovascular system safety pharmacology study Telemetry study hERG assay Nav 1.5 (Sodium Channel) test Cav 1.2 (Calcium Channel) test hiPSC-CMs-Based Multi-Electrode Array (MEA) Alternative toxicity test Local lymph node assay: BrdU-FCM, ELISA In vitro skin irritation test (RhE) In vitro eye irritation test (RhCE) In vitro 3T3 NRU phototoxicity test Medical device Genotoxicity test In vitro genotoxicity test In vivo genotoxicity test Cytotoxicity study Method: extraction study Method: direct contact studyt Method: indirect contact study Local effects after implantation study Subcutaneous Muscle Irritation study Skin irritation study Intracutaneous (intradermal) irritation study Skin sensitization study Guinea pigs skin sensitization study Systemic toxicity study Acute systemic toxicity study

Inspection agency

Ministry of Food and Drug Safety (MFDS)

Date of Initial accreditation

2002.08.12

Certification Status

Pharmaceuticals, foods, cosmetics, etc.

Single-dose toxicity study (Excluding inhalation route)

Repeated-dose toxicity study (Excluding inhalation route)

Reproductive·developmental toxicity studies

Fertility and early embryogenic development study
Embryo-fetal developmental toxicity study
Pre- and postnatal developmental toxicity study

Genotoxicity test

In vitro mammalian chromosome aberration test
In vitro mammalian cell micronucleus test
In vivo mammalian erythrocyte micronucleus test
Other genotoxicity test

in vitro mammalian cell gene mutation test (thymidine kinase gene)
In vivo mammalian alkaline comet assay

Antigenicity study

Active systemic anaphylaxis study
Passive cutaneous anaphylaxis study
Skin sensitization study

Carcinogenicity study

Local toxicity study

Skin irritation study
Eye irritation study

Local tolerance study

Other toxicity test

Photosensitization test
Phototoxicity test

Genotoxicity test

Bacterial reverse mutation test

Analytical study

Analytical test during toxicokinetic study
Other analysis study

Safety pharmacology study

Central nervous system safety pharmacology study
Respiratory system safety pharmacology study
Cardiovascular system safety pharmacology study

Telemetry study
hERG assay
Nav 1.5 (Sodium Channel) test
Cav 1.2 (Calcium Channel) test
hiPSC-CMs-Based Multi-Electrode Array (MEA)

Alternative toxicity test

Local lymph node assay: BrdU-FCM, ELISA
In vitro skin irritation test (RhE)
In vitro eye irritation test (RhCE)
In vitro 3T3 NRU phototoxicity test

Medical device

Genotoxicity test

In vitro genotoxicity test
In vivo genotoxicity test

Cytotoxicity study

Method: extraction study
Method: direct contact studyt
Method: indirect contact study

Local effects after implantation study

Subcutaneous
Muscle

Irritation study

Skin irritation study
Intracutaneous (intradermal) irritation study

Skin sensitization study

Guinea pigs skin sensitization study

Systemic toxicity study

Acute systemic toxicity study

Inspection agency	Ministry of Environment (ME)
Date of Initial accreditation	2008.09.03
Certification Status	Chemicals Acute oral toxicity study Acute dermal toxicity study Acute dermal irritation / corrosion study Acute eye irritation / corrosion study Skin sensitization study Subchronic toxicity study Chronic toxicity study Genotoxicity test Ames test Chromosome aberration test Micronucleus test In vitro mammalian gene mutation test Two-generation reproduction toxicity study Teratogenicity study Carcinogenicity study In vivo comet assay Alga growth inhibition study Daphnia sp. acute immobilisation study Fish acute toxicity study Local lymph node assay: BrdU-ELISA In vitro skin irritation: reconstructed human epidermis test In vitro eye irritation: reconstructed human cornea-like epithelium (RhCE) test In vitro 3T3 NRU phototoxicity test

Inspection agency	Rural Development Administration (RDA)
Date of Initial accreditation	2008.06.08
Certification Status	Agrochemicals Acute oral toxicity study Acute dermal toxicity study Skin irritation study Eye irritation study Skin sensitization study Ames test (bacterial reverse mutation test) Chromosome aberration test Micronucleus test Subacute oral toxicity study Subacute dermal toxicity study Teratogenicity study Chronic toxicity study Carcinogenicity study Combined chronic toxicity / carcinogenicity study Reproductive toxicity study Local lymph node assay-BrdU-ELISA Algae growth inhibition study Daphnia magna reproduction toxicity study Fish acute toxicity study

Inspection agency	Animal and Plant Quarantine Agency (APQA)
Date of Initial accreditation	2021.08.10
Certification Status	Veterinary drugs·medicinal products Acute toxicity study Subacute toxicity study Chronic toxicity study Skin Irritation study Reproductive toxicology study Teratogenicity study One-generation reproductive toxicity study Ames test Bacterial reverse mutation test Chromosome aberration test Micronucleus test Antigenicity study Active systemic anaphylaxis study Passive cutaneous anaphylaxis study Skin Sensitization study Local Lymph Node Assay, LLNA Other toxicity study Target animal safety study Eye irritation study Veterinary medical devices Biological safety assessment Cytotoxicity study Sensitization study Irritation or intradermal reactivity study Systemic toxicity study Genotoxicity test In vitro genotoxicity test In vivo genotoxicity test

Inspection agency

Animal and Plant Quarantine Agency (APQA)

Date of Initial accreditation

2021.08.10

Certification Status

Veterinary drugs·medicinal products

Acute toxicity study

Subacute toxicity study

Chronic toxicity study

Skin Irritation study

Reproductive toxicology study

Teratogenicity study
One-generation reproductive toxicity study

Ames test

Bacterial reverse mutation test
Chromosome aberration test
Micronucleus test

Antigenicity study

Active systemic anaphylaxis study
Passive cutaneous anaphylaxis study

Skin Sensitization study

Local Lymph Node Assay, LLNA

Other toxicity study

Target animal safety study
Eye irritation study

Veterinary medical devices

Biological safety assessment

Cytotoxicity study
Sensitization study
Irritation or intradermal reactivity study
Systemic toxicity study

Genotoxicity test

In vitro genotoxicity test
In vivo genotoxicity test

BUSINESS

Nonclinical CRO Business Unit

Pharmaceuticals, foods, cosmetics, etc.

Medical device

Chemicals

Agrochemicals

Veterinary drugs·medicinal products

Veterinary medical devices