Center Introduction

    About US

    Shanghai InnoStar Biotech (also named National Shanghai Center for New Drug Safety Evaluation and Research, NCDSER), conveniently located in Zhangjiang Hi-Tech Park Shanghai, is the first GLP lab certified by CFDA. Besides, InnoStar were also inspected by US FDA and by one of the OECD member countries, Netherlands. We offer a breadth of high quality services including nonclinical toxicology, DMPK, in vitro biological assays, clinical sample analysis, and regulatory service. Our lab is staffed by professionals and experts and equipped with state-of-art equipment. We provide our customers with integrated services from early drug discovery to clinical development. Our AAALAC-accredited animal facility has 28 SPF-grade small animal rooms and 32 conventional large animal rooms. We conduct toxicology and DMPK studies in a variety of animal species (NHPs, canines, rodents, guinea pigs, rabbits, etc.) with different routes of administration (oral, i.v., s.c., i.m. dermal, etc.). We are now expanding our business and building a new site in Jiangsu Province, and our capacity will be doubled in the near future.



Accreditation & Certification

        CFDA GLP Certificate (2003, 2006, 2011, 2015)

        AAALAC Accreditation (2008, 2010, 2014)

        OECD GLP Certificate (Netherlands) (2012, 2015, 2017)

        US FDA GLP Inspection (2014)

        CAP Accreditation (the College of American Pathologists’ Laboratory Accreditation Program) (2015)

        CMAF Certificate (2016)

Experienced/Skilled Team

        5 panel members of CFDA CDE for new drug and food evaluation

        4 senior CFDA GLP inspectors

        3 AAALAC inspectors

        2 US RQAP-GLP QA auditors

        2 pathologists with JCVP (Japanese College of Veterinary Pathologists) and JSTP (Japanese Society of Toxicological Pathology)

       11 study directors with CTCST (Certified Toxicologist of China Society of Toxicology)

        2 veterinarians with LAM (Laboratory Animal Medicine)(Canada)

Evaluated Projects

        561 chemical drugs

        112 biologic drugs

        22 Chinese herbal medicine

Services

        Nonclinical toxicology studies

        PK studies

        In vitro efficacy and biomarker assays

        Clinical sample bioanalysis

        Consulting & Regulatory Services