Robert, as a consultant, provides inspection readiness and compliance guidance to biologicals, vaccines, and cell and gene therapy manufacturing clients. Robert is responsible for performing Pre-Approval Inspection Assessments, preparing sites for the first inspection and assisting with regulatory submission for CMC, IND, BLA, CAT and MAA. Robert has more than 30 years of experience in the biopharma and vaccines businesses, including various roles in validation and compliance in both drug substance and drug product manufacturing in the United States, European Union, South America and Asia.