Preclinical Safety Evaluation

As a domestic safety evaluation institutions leader, we have toxicology studies experience for more than 50 years, have the CFDA GLP certificate, the OECD GLP certificate, AAALAC certificate, we also passed the US FDA GLP inspection. we have the ability of single dose toxicity test, repeated dose toxicity test, safety pharmacology test and local toxicity test, immune toxicity test, reproductive toxicity test, genetic toxicity test, carcinogenic test, toxicokinetics test. The experimental system including mice, rats, guinea pig, rabbits, dogs, miniature pig and non-human primates. At present, our company has provided thousands of toxicology evaluation services for customers, including Chinese medicine and natural medicine, chemical medicine and biological products. We have experienced professional toxicology researchers who can ensure the smoothly carrying out of tests and can provide scientific and accurate reports to our customers.

Service projects

Dose exploration test

Single dose toxicity test

Repeated dose toxicity test

Safety pharmacology test

Local toxicity test（allergy, hemolysis and irritation）

Genetic toxicity test

Bacterial reverse mutation (Ames) test

In vitro mammalian cell micronucleus test

In vivo mammalian cell micronucleus erythrocyte test

In vitro mammalian chromosomal aberration test

In vitro mouse lymphoma cell TK gene mutation assay (MLA)

In vivo mammalian alkaline comet assay

Reproductive toxicity test(Ⅰ、Ⅱ、Ⅲ stage )

Carcinogenic test(mice、rat)

Toxicokinetics test

Guidelines followed

The technical guidelines for non-clinical research issued by CFDA.

ICH S series guidelines.

Refer to the preclinical evaluation principles of USFDA, EMA and ICH.

Platform of qualification

"National shenyang new drug safety evaluation and research center" recognized by the Ministry of Science and Technology.

"Liaoning provincial new drug safety evaluation technology research center" recognized by Liaoning Provincial Science and Technology Department.

Having qualifications including OECD GLP, CFDA GLP, AAALAC, and passing US FDA GLP inspection in 2018

Instruments and equipment

Immunohistochemical study automatic closed machine, automatic device, slicing digital scanning device, electrophysiological instrument, automatic detector, automatic blood coagulation analyzer, automatic urinary formed elements analyzer, biochemical analyzer, sperm analyzer, flow cytometry, multifunctional enzyme mark, UPLC, HPLC and LC - MS and GC - MS, etc.

Business consulting

Ms.Li   +86   024-85869185/ 18540366476