TriApex is a study facility that got GLP certification early by NMPA, where the facility operation and study implementation both comply with NMPA, FDA and OECD GLP regulations. We have rich practical experience in nonclinical safety research, and can conduct various nonclinical studies of different products in various animal species according to regulatory requirements or sponsor demands to efficiently support the clinical development and marketing approval.
Service Advantages1. Compliance
TriApex is a nonclinical study facility that got GLP certification early by NMPA, and is capable of carrying out whole package of non-clinical safety studies of drugs in compliance with NMPA, FDA and OECD GLP regulations.
2. Quality Management System
TriApex has built a high-quality management system with experienced quality assurance (QA) team and comprehensive quality control (QC) process.
3. Project and data management system
By using the efficient project management software, the content and progress of nonclinical research project are visualized. International mainstream data management systems (e.g. Provantis, WATSON LIMS, etc.) are used to comprehensively and efficiently manage nonclinical research data.
4. One-stop services
TriApex can provide one-stop services including nonclinical efficacy, pharmacokinetics, and toxicology studies, regulatory strategy and IND submissions. We have supported IND applications of over 100 programs, including new chemical entities (including siRNA and its delivery systems), biologics (including antibodies, ADC, peptide drugs), cell therapies, gene therapies and traditional Chinese medicines.
Service CapacitiesService |
Single dose toxicity study Repeat dose toxicity study Genotoxicity study Carcinogenicity study Reproduction toxicity study (fertility and early embryonic developmental study (FEED), embryo-fetal development study (EFD), pre- and postnatal development study (PPND)) Juvenile animal study Local tolerance study Safety pharmacology study Dose range finding study |
Route of Administration |
Oral Subcutaneous injection Intradermal injection Intraperitoneal Injections Intramuscular injection Intravenous injection Intra-articular injection Intraventricular injection Percutaneous administration Intranasal administration |
Supporting Services |
Formulation concentration analysis Drug concentration determination in biological samples Immunogenicity Immunotoxicity Pharmacokinetics Toxicokinetics Histopathology slides preparation and interpretation SEND Translation Submission dossier preparation Others |
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