•Managed client’s GMP manufacturing site

•Preparation and hosting of regulatory inspections

•Obtained OECD GLP compliance certification for Singapore client

•Assisted client with remediation of GMP systems as per FDA warning latter

•Development of biosimilar products

•First GLP validation of a gene expression assay for clinical trail support

•Resolved 483 Issues Leading to a successful client PAI (medical device)

•Established and managed QA/QC departments

•Conducted due diligence audits

•Created QA documentation systems

•Established regulatory archive

•Performed GMP and GLP audits

•Assay transfer: Development lab to clinical testing facility

•Medical device biocompatibility testing

•Prepared clients for regulatory compliance inspections

•Established complete GMP and GLP SOP systems

•Guided ICH compliant QC assay panel validation

•Guided 21 CFR Part 11 computer system validation

•Oversight of client instrument validation (IQ, OQ, PQ)

•Clinical lab software validation

•GLP compliant LIMS/database development and validation

•Prepared client for FDA PAI inspection

•GLP audit of Chinese labs for US client