The US based contract research organisation (CRO) said that certification enables its Taiwan unit to begin offering analytical support services for both preclinical research and clinical development.
Yen said that the DoH based its decision on the firm’s track record, infrastructure and library of standard operating procedures (SOPs) that are employed at all of the firm’s research labs worldwide.
He explained that the lab, which is located in Taiwan’s Nan Kang Biotech Park, houses API 4000 triple quadrupole mass spectrometers, Shimadzu VP-series LCs, Tomtec Quadra, managing those using Rees Monitors and a Watson LIMS system.
QPS’ CEO, Ben Chien, said: “We view this as an additional assurance to our sponsors that the QPS state-of-the-art, Asian bioanalytical LC/MS/MS facility has the same high quality and operational standards as our FDA-audited QPS US facility.”
Taiwanese Biotech
In the 1980s the Taiwanese government began to invest in biotechnology R&D, spending around 30 per cent of its annual science budget on the sector which was, at the time, still relatively small.
This investment resulted in the development of three science bases: Hsinchu; the Central Taiwan Science Park and the Southern Taiwan Science Park, which generated revenues of $60.8bn in 2008 according to the National Science Council (NSC).
This infrastructure has proved irresistible to industry players like Applied Biosystems, Invitrogen, Dionex and Novartis which, in addition to German drugmaker Merck KGaA, all have an established presence in the country.
“Promotion plan” to attract CROs
Despite Taiwan’s success in attracting the pharmaceutical industry, the country’s contract research sector, has until recently, remained relatively small according to center for drug evaluation (CDR) executive director Herng-Der Chern.
In an interview with BioSpecturm in March last year Chern said: “There is shortage of supply of skilled workforce in the segment because of the booming demand even though many CROs have set up intensive training course to nurture their staff.”
In response, the Taiwanese government instituted a “promotion plan” designed to attract contractors to the country.
The plan grants rights to CROs to submit investigational new drug (IND) applications and provides pharmaceutical sponsors with a number tax incentives relating to their outsourcing spend.