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臨床試驗受託機構

昌達生化科技股份有限公司 QPS Taiwan (Quest Pharmaceutical Services, Taiwan)

卓越成果

Founded in 2004, QPS Taiwan is a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development. We provide quality services to pharmaceutical and biotechnology clients worldwide. Our linearly integrated core competencies include DMPK, toxicology, bioanalysis, early phase clinical research, and project management.

Successful US FDA inspection in July 2015

>1,200 pre-clinical/toxicology GLP studies

>25 dossiers compiled for US FDA IND submission

>20 dossiers compiled for Taiwan TFDA IND submission

REACH registration

>100 BE studies approved by Taiwan FDA since 2004

>370 Phase I, BA/BE/PK studies since 2004

> 5,500 healthy subjects and > 150 patients

Phase I, first-in-human, PK or PK/PD studies

ANDA BE studies for US FDA & EMA filing

BE studies with oncology patients

Cooperate hospitals for phase I, BA/BE/PK studies

TVGH: establish “TVGH/QPS Clinical R&D Center” in 2011

TMUH: collaborated >300 BE studies

TSGH, CMUH , CTHYH, NTUH, CGMH-LK, VGH-TC, NCKUH, VGH-KS…

> 50 global phase I PK projects (PK analysis & report)

Bioanalysis supporting to:

Clinical trials with samples from US, Europe, Japan, Korea, Australia…

US FDA first-to-file 

專長服務項目

  • Toxicology & Pre-clinical Service
  • Early Phase Clinical Research Service
  • LC/MS/MS Bioanalysis Service
  • Immunogenicity and Biomarkers

提供實驗室服務

國際認證

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