QPS Taiwan (CTPS)
No. 103, Lane 169,
Kangning St., Xizhi Dist.,
New Taipei City 22180,
Taiwan
0
IND Dossiers Submitted
0
GLP Studies Completed
0
Square Feet of Lab Space
0
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.
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.
