51
IND Dossiers Submitted
1,800
GLP Studies Completed
31,000
Square-Foot Facility
50+
Employees
QPS Taiwan (CTPS)
- QPS Taiwan (CTPS) is a GLP-compliant Clinical 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 with a “No Finding” result (July 2015).
- Nine (9) Taiwan Accreditation Foundation (TAF) Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) inspections (as of November 2019)
- Four (4) Department of Health (DOH) / Ministry of Health and Welfare (MOHW) GLP inspections (as of November 2019).
- 30+ client audits with satisfactory outcomes (as of May 2019).
Accreditation
- 1st GLP voluntary inspection in Taiwan (July 2012).
- Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accreditation (February 2018).
- OECD (TAF) GLP (November 2019).
- ISO/IEC 17025 inspection (September 2019).
- 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
