No. 103, Lane 169,
Kangning St., Xizhi Dist.,
New Taipei City 22180,
Taiwan
Kangning St., Xizhi Dist.,
New Taipei City 22180,
Taiwan
51
IND Dossiers Submitted
1,800
GLP Studies Completed
31,000
Square Feet of Lab Space
50+
Employees
QPS Taiwan (CTPS)
- QPS Taiwan (CTPS) is a GLP-compliant Contract Research Organization (CRO) specializing in Toxicology and safety studies.
- Located in the Xizhi District in New Taipei City, the facility encompasses 31,000 square feet, with 50+ employees.
Core Competencies
- Genetic toxicology.
- General toxicology.
- Reproductive (segment II) toxicology.
- Pharmacokinetics with bioanalysis.
- General toxicity testing.
- Biocompatibility testing.
- Topical toxicity testing.
Facility
- On-site dose analysis, bioanalysis, clinical pathology, and histopathology by Diplomate of the American College of Veterinary Pathologists (DACVP).
- Gold-standard animal sourcing (such as Charles River, Marshall, and Oriental Yeast).
- Remote-video study monitoring.
- State-of-the art automatic data collection system (Xybion Pristima®).
- In-house Standard for Exchange of Non-Clinical Data (SEND) module by the Xybion system.
People
- US board-certified pathologists.
- Highly experienced toxicologists: all are US-, EU-, and Japan-trained (Diplomat of the American Board of Toxicology [DABT] and DJST).
- Highly experienced Quality Assurance (QA) personnel, registered with Society of Quality Assurance (SQA).
Achievements
- 1st Toxicology CRO in Taiwan to be inspected on-site by the US FDA (July 2015).
- Successful GLP US FDA Inspections (latest April 2023)
- Ten (10) Taiwan Accreditation Foundation (TAF) Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) inspections (as of October 2021).
- Six (6) Department of Health (DOH) / Ministry of Health and Welfare (MOHW) GLP inspections (as of October 2021).
- 30+ client audits with satisfactory outcomes (as of February 2022).
Accreditation
- 1st GLP voluntary inspection in Taiwan (November 2007).
- AAALAC International: Full accreditation since 2000. Last “full accreditation continued” certification received in June 2021.
- OECD GLP inspection by TAF (valid thru April 2024).
- ISO/IEC 17025 inspection by TAF (valid thru March 2024).
- European Union (EU) Quality Management System (QMS) audit (July 2018).
Experience
- Over 2,000 GLP studies conducted since 1997.
- 35+ dossiers compiled for US FDA IND submissions.
- 25+ dossiers compiled for Taiwan IND submissions.
- Large/small molecule and device development expertise.
- Established global procedures for sample shipping and data analysis.
Bioanalytical Services
- Blood and urine sampling.
- Plasma concentration.
- Dosing formulation analysis.
Leadership
Vincent Yen, MBA
Regional General Manager, Asia
