Certifications & Accreditations

Scope of GLP Certification

1. General Toxicity
　Single dose toxicity study (Limited to rodent, dogs, and rabbits; excluding the inhalation route of exposure)
　Repeated dose toxicity study (Rodent and non-rodent, excluding the inhalation route of exposure)
2. Reproductive and developmental toxicity
　 Fertility and early embryonic development study
　 Rodent & non-rodent Embryo-fetal development study
　Pre- and postnatal development and maternal function study
3. Carcinogenicity
　Carcinogenicity study
4. Genotoxicity
　Bacterial reverse mutation test
　In vitro chromosome aberration test
　 In vitro micronucleus test
　 In vivo chromosome aberration test
　 In vivo micronucleus test
　 In vitro mouse lymphoma TK assay
　 In vivo comet assay
　 In vivo Pig-a gene mutation assay
5. Antigenicity
　Anaphylactic shock reaction test
　Passive skin anaphylactic reaction test
　Skin sensitization test
6. Local toxicity, irritation and sensitization
　Skin irritation test
　Mucous membrane irritation test
　Local tolerance test
　Skin sensitization test
　Photosensitization assay
　Phototoxicity test
7. Analytical studies
　Analytical test during the toxicokinetics studies
　Other analytical studies
8. Safety pharmacology
　Assessment of effects on the CNS
　Assessment of effects on the respiratory system
　Assessment of cardiovascular effects
　Telemetry assay
　hERG assay
　Nav1.5 (sodium channel) assay
　Cav1.5 (calcium channel) assay
　 hiPSC-CMs based Multi-Electrode Array (MEA) assay
9. Alternative test methods
　In Vitro 3T3 NRU Phototoxicity Test
　Local Lymph Node Assay (LLNA) using the ELISA method
　Eye Irritation Test using a Reconstructed Human Cornea-like Epithelium (RhCE) model
　In Vitro Skin Irritation Test using a Reconstructed Human Epidermis (RhE) model

Scope of GLP Certification

1. Genotoxicity study
　A. In vitro genotoxicity study
　B. In vivo genotoxicity study
2. Blood Compatibility Study
　- In vitro study
3. Cytotoxicity Study
　 - Elution study
　 - Direct contact test
　 - Indirect contact test
4. Implantation Test
　- Implantation test in subcutaneous tissue
　- Intramuscular implantation test
5. Irritation and Skin Sensitization Test
　- Irritation test including intradermal reaction
　　A. Irritation test using animal [skin irritation]
　　 B. Intracutaneous reactivity test in animal
　　C. Ocular irritation test
　　D. Oral mucosal irritation test
　- Skin sensitization [delayed hypersensitivity] test
　　 A. Mouse topical lymph node test
　　 B. Guinea pig test for detection of skin sensitization
6. Systemic Toxicity Study
　- Acute systemic toxicity study
　- Repeated exposure systemic toxicity study
　　A. Subchronic [subacute] systemic toxicity study
　- Pyrogen study
　　A. Endotoxin mediated pyrogenicity

Scope of GLP Certification

1. Acute, Repeated-Dose and Local Toxicity Studies
　Acute oral toxicity, Acute dermal toxicity, Subacute toxicity, Chronic toxicity, Acute dermal irritation/corrosion, Acute eye irritation/corrosion, Skin sensitization
2. Carcinogenicity Study
　Carcinogenicity
3. Reproductive and Developmental Toxicity Studies
　Two-generation reproduction toxicity, Teratogenicity, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
4. Genotoxicity Studies
　Genetic toxicity (Ames test, Chromosome aberration test, Micronucleus test), In vivo comet assay, Genetic toxicity In Vitro Mammalian Gene Mutation Test, In Vitro Mammalian Cell Micronucleus Test
5. Alternative Test Methods (Dermal, Ocular and Phototoxicity)
　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, In vitro Skin Irritation: Reconstructed Human Epidermis Test
6. Physicochemical Properties
　Partition Coefficient (n-octanol/water): Shake Flask Method/ HPLC Method
7. Degradation Studies
　Manometric Respirometry Test
8. Ecotoxicity Study
　Alga Growth Inhibition Test, Daphnia sp. Acute Immobilisation Test, Fish Acute Toxicity Test

Scope of GLP Certification

[Toxicity]
1. Acute oral toxicity, Acute dermal toxicity
2 .Subacute oral toxicity, Subacute dermal toxicity, Chronic toxicity
3. Skin irritation, Eye irritation
4. Skin sensitization
5. Teratogenicity
6. Ames test, Chromosome aberration test, Micronucleus test
7. Carcinogenicity, Combined Chronic toxicity/Carcinogenicity
8 .Reproductive toxicity

[Ecotoxicology]
1 . Alga Growth Inhibition Test
2. Daphnia sp. Acute Immobilisation Test
3. Fish Acute Toxicity Test

Scope of GLP Certification

[Animal Drugs]
1. General Toxicity
- Acute toxicity study ( Rodent and non-rodent)
- Subacute toxicity study ( Rodent and non-rodent)
- Chronic toxicity study (Rodent)
2. Reproductive toxicity
- Teratogenicity study (Rodent and non-rodent)
- 1st generation toxicity study
3. Mutagenicity
- Bacterial reverse mutation test
- In vitro chromosome aberration test
- In vivo micronucleus test
4. Skin irritation study
5. Immunotoxicity study
- Antigenicity test
- Anaphylactic shock reaction test
- Passive skin anaphylactic reaction test
- Skin sensitization test
- Guinea pig maximization test, Buehler test
- Mouse local lymph node assay (LLNA)
6. Other studies
- Target animal safety study
- Ocular irritation test

[Animal Medical Device]
1. Cytotoxicity Study
2. Irritation and Skin Sensitization Test
3. Systemic Toxicity Study
4. Other studies
- In vitro genotoxicity study
- In vivo genotoxicity study