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Service Capabilities

Service Capabilities

Service Capabilities
Nonclinical Safety Evaluation
Nonclinical Safety EvaluationPharmacokinetic EvaluationPharmacodynamic EvaluationBioanalysisMolecular Imaging and AnalysisMedical Device Testing

Nonclinical Safety Evaluation

Topgenebio provides GLP-compliant preclinical safety evaluation services for chemical drugs, traditional Chinese medicine, and biotechnological drugs, meeting both domestic and international regulatory requirements for submission.



Area: Over 24000㎡

Project Experience:
Over 1200 specialized studies
Over 200 varieties of new drug declarations
Over 60 domestic and international declaration projects



Service Scope

1. Single-dose toxicity studies (rodent,non-rodent species,non-human primates)
2. Repeat-dose toxicity studies (rodent,non-rodent species,non-human primates)
3. Reproductive toxicity studies (Phase l , ll and lll)
4. Genetic toxicity studies(Ames,micronucleus,chromosomal aberration,mouse models in lymphoma research)
5. Local toxicity studies
6. lmmunogenicity studies
7. Safety pharmacology studies
8. Toxicokinetics studies
9. Carcinogenicity studies

Experimental Animal Species

Rodents (mice, rats, hamsters, guinea pigs)

Non-rodents (rabbits, dogs, NHPs, etc.)

  • Advantages

    Our core team consists of multiple new drug evaluation experts and GLP senior technical experts with over 20 years of project research experience, ensuring strict scrutiny of the scientific and regulatory aspects of technical proposals and reports. Key personnel have over 10 years of experience in pharmacokinetics/pharmacology/toxicology, ensuring the quality of project research.
    We utilize the Pristima/Provantis GLP Tox system to ensure the accuracy, completeness, standardization, and efficiency of data.
    We independently own four monkey facilities with abundant animal resources, ensuring the quality and supply of experimental animals, thereby saving overall project time.

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