BEIJING--(BUSINESS WIRE)--Pharmaron announced today that the company has received a Certificate of GLP Compliance, covering genetic toxicology and reproductive toxicology (DART Segments I and II), from the Chinese Food and Drug Administration (CFDA) for its GLP safety assessment facility in Beijing. This is the second GLP compliance certificate granted to this facility by the CFDA since 2013. As such, Pharmaron can offer full IND-enabling safety assessment services to partners in support of their IND filings with the CFDA.
Dr. Boliang Lou, Pharmaron Chairman and CEO, commented, “this certificate is another testimony of our determination for our safety assessment facility to be fully compliant with the CFDA GLP guidelines and a reflection of the CFDA’s continued confidence in our quality. Our customers once again can be assured of the high quality of our safety assessment services. Integrated with other already established platforms including DMPK, pharmacology and CMC at Pharmaron, this further strengthens our leading position in providing integrated preclinical services, including those required for IND filing with the CFDA, for biopharmaceutical and biotech companies in China and throughout the world, to facilitate the development of safer drugs for patients.”
Pharmaron is a private, premier R&D service provider for the life science industry. Founded in 2003, Pharmaron has invested in its people and facilities, and established a broad spectrum of drug R&D service capabilities, ranging from synthetic and medicinal chemistry, biology, DMPK, pharmacology and safety assessment to chemical & pharmaceutical development. Its safety assessment platform has a long-standing track record of performing studies for international IND/NDA filing, particularly with the US FDA. With the addition of the CFDA-granted GLP compliance certificates since 2013, Pharmaron is in a leading position in providing IND/NDA-enabling services for multiple regulatory filings, including the CFDA, US FDA and OECD regulatory agencies. For more information, please visit www.pharmaron.com.