Michael Zhou

MichaelZhou, Ph.D.is a Senior Principal Consultant in Analytical Quality Control & Regulatory Compliance Practices for Life Science Industries, who is an accomplished Lead Scientist with analytical and bio-analytical R&D and manufacturing experience in support of drug / product R&D, Clinical and CMC programs. He has over 15 years of ADMET/Pharmacokinetics Leadership skills in both sponsor and contract researchorganization settings and has focused on analytical and bioanalytical R&D andCMC plus Drug Metabolism and Pharmacokinetics (DMPK) programs for over 20 years. He has expertise in GxP regulations and ICHguidelines, and is knowledgeable in USFDA, USDA, EPA, EEC, EMA, OECD and ICHglobal regulations (GLP, GCP, cGMP or GxP), guidelines and standards / certifications(USP, ISO, etc.) for life science industries and related perspectives / issues. During his career tenure, he has successfullyassisted, consulted and gone through FDA Consent Decree (CDs), Warning Letters(WLs) and other compliant issues. He has led teams in resolving issues, tackling problems and executing remediation processes (route cause analysis, CAPA assessments and resolutions). He has been also actively involved inorganizing conferences, speaking at presentations, and sharing his knowledge atworkshops and short courses for numerous national and internationalproceedings. Dr. Zhou has authored over40 research articles and 2 book chapters and is the author of a recentlypublished book in 2011 entitled: “RegulatedBioanalytical Laboratories: Technical and Regulatory Aspects from GlobalPerspectives”. Dr. Zhou is a peer reviewer of many renownedinternational technical journals and is on the Editorial Board for“Bioanalysis” London, UK and Journal of Drug Metabolism and Pharmacokinetics byOMICS Group.

Expertise

§ Provide managerial, technical,scientific, and regulatory compliance expertise and guidance for GxP analytical/ bioanalytical R&D, QC laboratory and clinical operations to ensure quality andintegrity of data for management assessment, decision-making, CMC processes anddata submissions

[if !supportLists]§ [endif]Provide technical andregulatory support for analytical and bioanalytical method development,validation, and trouble-shooting including HPLC, GC, LC-MS/MS, GC-MS/MS, ELISA/LBAs,Biomarker Assays (in-vitro diagnostic kits), CE, SDS-PAGE and other techniquesin support of ADMET and DMPK proje