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01.
Single-dose Toxicity Studies (rodent, non-rodent species, non-human primates)
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02.
Repeat-dose Toxicity Studies (rodent, non-rodent species, non-human primates)
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03.
Reproductive and Developmental Toxicity Studies (Phase l , ll，lll and NHP ePPND)
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04.
Genetic Toxicity Studies
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05.
Local Toxicity Studies
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06.
lmmunogenicity Studies
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07.
Safety Pharmacology Studies
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08.
Toxicokinetics Studies
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09.
Carcinogenicity Studies
Service Capability
Topgenebio provides GLP-compliant nonclinical safety evaluation services for chemical drugs, traditional Chinese medicine, and biotechnological drugs, meeting both domestic and international regulatory requirements for submission.
Advantages
- Our core team consists of experts in non-clinical efficacy and safety evaluation of new drugs, as well as GLP specialists, each with over 20 years of project research experience.They are capable of reviewing study protocols and reports from both scientific and regulatory compliance perspectives. The key technical personnel all have more than 10 years of experience in pharmacokinetics/pharmacology/toxicology, ensuring project quality.
- We utilize the Pristima/Provantis GLP Tox system to ensure the accuracy, completeness, standardization, and efficiency of data.
- Perinatal developmental toxicity study in rats/mice with toxicokinetics (Segment III, up to F2 generation behavior)
Service Scope
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Topgene Biotechnology -
marketing@topgenebio.com -
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