Chandan Thomas

Background

About Chandan Thomas

EX-FDA Regulatory and Policy Analyst-Expert Biologic/Biotechnology Product Quality Assessor at the US FDA. Ensured the safety and quality of biologic products for human use from CMC/product quality perspective. I have close to 10 years of experience in CMC regulatory review and enforcement, specializing in injectable, ophthalmic, oral, and combination drug products, as well as complex generic drug products. My mission at the FDA was to protect public health by applying my knowledge and skills in formulation development, drug delivery, nanotechnology, and analytical methods to evaluate the quality and compliance of small molecule and biologic/ biotechnology products. Led and co-led policy and guidance development and implementation teams at Office of pharmaceutical quality in CDER, eg, Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency; pre-approval compliance programs, emerging technologies per CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative such as distributed manufacturing and point of care technology (POC), OPQ CMC lead for 505b2 NDAs, complex ANDAs. Currently, I am an Associate Director for Regulatory Affairs at Sandoz Inc.