QPS Taiwan (NKSP)

Core Competencies

• Early Phase clinical development (Phase I → Phase IIa) includes bioavailability/bioequivalence/PK/PD studies that support NDA or ANDA registration for Taiwan FDA, China FDA, and US FDA.
• Bioanalysis (small molecules → biologics), in compliance with US FDA registration.
• Large molecule: PK, ADA, biomarkers, cell-based nab assay, cell-based potency assay over ELISA/Bio-Plex/cell assay platforms, and immunogenicity monitoring using a four-tier approach.
• Close collaboration with the QPS Global team (i.e. medical writing, PK, PD, biostatistics, and data management).

Facility

• Early Phase clinical development (Phase I → Phase IIa) includes bioavailability/bioequivalence/PK/PD studies that support NDA or ANDA registration for Taiwan FDA, China FDA, and US FDA.
• Bioanalysis (small molecules → biologics), in compliance with US FDA registration.
• Large molecule: PK, ADA, biomarkers, cell-based nab assay, cell-based potency assay over ELISA/Bio-Plex/cell assay platforms, and immunogenicity monitoring using a four-tier approach.
• Close collaboration with the QPS Global team (i.e. medical writing, PK, PD, biostatistics, and data management).

Achievements

• 1st CRO in Taiwan to be inspected on-site by the US FDA with a “No Finding” result (July 2015).
• US FDA: 1 successful inspection (ANDA) at TMUH (1st in Taiwan, June 2016).
• US FDA BE bioanalysis on-site inspection with “No Finding” (June 2016).
• Malaysia NPRA: 2 successful inspections at TMUH (which is a qualified BE center) in 2014 and 2017.
• 1st TFDA GLP voluntary inspection (September 2009).
• 23 client audits with satisfactory outcomes (as of July 2018).

Accreditation

• Successful US FDA inspection without any findings or 483 (July 2015 and June 2016).
• 1st TFDA GLP certificate (September 2009).
• Malaysia NPRA BE center certificate (November 2014 and April 2017).

Experience

• Over 400 Phase I/BA/BE of HV studies conducted since inception in 2004.
• Over 100 generics BE studies approved by TFDA, including FIH (1), US ANDA (1+), EMA filing (1), China filing (25+), and Malaysia filing (5).
• Studies have involved over 7,000 healthy subjects and over 150 patients.
• Administration routes: PO, IV, IM, SC, nasal sprays, and oral inhalation.
• Extensive validated assay list (1,000+ assays and growing).
• Over 500 bioanalysis studies conducted, along with over 120,000 samples analyzed.

Quality Management Systems

• SOP administration.
• Employee qualifications.
• Equipment program.
• Validation team (users, IT, QA, and management), validation plan, IQ/OQ/PQ.
• Deviations/CAPA.
• Quality assurance audits.
• Archives/repository.