QPS Taiwan NKSP
3 Yuan Chu Street, 12th Floor,
Nankang District Taipei,
Taiwan
Healthy Subjects Enrolled
0
GLP Studies Completed
0
Sq. ft. of Lab Space
0
Employees
0
QPS Taiwan NKSP Virtual Tour
INFOGRAPHICS
Bioanalysis Equipment
EPC and Bioanalysis Services
Histology Equipment
By the Numbers
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
- 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.
QPS Taiwan NKSP
- QPS Taiwan (NKSP) is a GLP/GCP-compliant CRO that supports discovery, preclinical, and clinical drug development.
- It was established in 2004 and is located at Nankang Software Park in Taipei, with 14,000 square feet of space and 40+ employees.
