CRO SERVICE
2000
+
Toxicology and safety assessment
40
+
NHP disease models
1000
+
Development and validation of traditional analytical methods for chemical drugs
500
+
Bioassay development and validation
40
+
Non-clinical research and development of medical devices
315
+
Clinical product items
CRO SERVICE
Disease Models and Pharmacodynamics
Disease Models and Pharmacodynamics
Ophthalmic Disease

鼎泰集團擁有符合AAALAC标準的非人靈長(cháng)類動物(NHP)飼養設施與一流的生物分析、病理、臨床檢驗和生物标志物實驗室。依托于豐富的NHP疾病模型,專注于代謝、神經(jīng)、心血管、肝腎、眼科及免疫炎症等疾病領域,開(kāi)展具有更高臨床轉化價值的藥效學(xué)/藥代動力學(xué)研究及相關機制研究,鼎泰在提供高品質服務的同時,已與衆多的國(guó)内外藥企、生物技術公司和學(xué)術機構研究建立了值得信賴的合作基礎。

CNS Disease

鼎泰集團擁有符合AAALAC标準的非人靈長(cháng)類動物(NHP)飼養設施與一流的生物分析、病理、臨床檢驗和生物标志物實驗室。依托于豐富的NHP疾病模型,專注于代謝、神經(jīng)、心血管、肝腎、眼科及免疫炎症等疾病領域,開(kāi)展具有更高臨床轉化價值的藥效學(xué)/藥代動力學(xué)研究及相關機制研究,鼎泰在提供高品質服務的同時,已與衆多的國(guó)内外藥企、生物技術公司和學(xué)術機構研究建立了值得信賴的合作基礎。

Metabolic Disease
CVD and Other Disease

鼎泰集團擁有符合AAALAC标準的非人靈長(cháng)類動物(NHP)飼養設施與一流的生物分析、病理、臨床檢驗和生物标志物實驗室。依托于豐富的NHP疾病模型,專注于代謝、神經(jīng)、心血管、肝腎、眼科及免疫炎症等疾病領域,開(kāi)展具有更高臨床轉化價值的藥效學(xué)/藥代動力學(xué)研究及相關機制研究,鼎泰在提供高品質服務的同時,已與衆多的國(guó)内外藥企、生物技術公司和學(xué)術機構研究建立了值得信賴的合作基礎。

Regulatory Strategies and Safety Assessment
Regulatory Strategies and Safety Assessment
Regulatory Strategy

The development of clear and accurate regulatory strategy is crucial in ensuring the quality of R&D and expediting product launches. Drawing from our extensive experience in industrial product development and regulatory evaluation, the Regulatory Strategy Team at TriApex offers clients services in three areas: regulatory strategy, registration application, and technical consulting/training.

Drug Metabolism and Pharmacokinetics

TriApex DMPK team is committed to providing pharmacokinetic research services for PK R&D studies at various research stages, including leading compound discovery and optimization, PCC identification, and other phases, to facilitate drug R&D from non-clinical to clinical stages.

Drug Safety Assessment

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.


Safety Assessment of Medical Devices

TriApex provides our clients medical device services, including development strategies, methodological development and validation, pre-clinical safety assessment, regulatory affairs and quality consultation, and medical writing. TriApex, dedicated to shortening the R&D time, reducing the R&D costs, protecting intellectual property, and promoting successful registration and market approval for our clients, is a high-quality partner of medical device innovation and clinical training.

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