QPS Taiwan (CTPS)

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

• 1^st 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

• 1^st GLP voluntary inspection in Taiwan (July 2012).
• Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC): Full accreditation since 2018. Last “full accreditation continued” certification received in June 2021.
• OECD (TAF) GLP (April 30, 2020).
• ISO/IEC 17025 inspection (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.