Dr. Chris Tudan is a regulatory Bioanalytical expert who has worked in a variety of Bioanalytical labs, developing and validating both ligand-binding, cell-based, PCR and LC-MS/MS assays in the role of both Sponsor and CRO. He is president of BioAccurate Enterprises, Inc., a consulting firm that provides technical and regulatory expertise to the regulatory and drug development community. He also trains biopharmaceutical QAU staff and bioanalytical scientists the science and compliance associated with GLP bioanalysis.
Chris trained as a drug discovery biochemist and has been involved in the development of many assays for discovery and characterization of both small and macromolecules (including peptide memetics), resulting in numerous patents, publications and clinical submissions. He has utilized LC-MS/MS and LBA’s throughout his career, developing and validating bioanalytical methods, including GLP-compliant DDI methods, in GLP labs. Chris offers a unique ability to merge the regulations associated with bioanalysis in a GLP environment with the technical and specific method-related details.