Charu Srinivasan, PhD US FDA

Dr. Charudharshini Srinivasan is currently at the US-FDA, as a Research Scientist and a Reviewer in the Office of Testing and Research (OTR), Center for Drug Evaluation and Research (CDER). Her work focuses on regulatory research on parenteral formulations and packaging; use of process analytical technology in lyophilization process understanding; evaluation of drug product quality and regulatory review. She currently serves as the government liaison to the USP Expert Committee -Glass Expert Panel. She is also the OTR representative for emerging technology program (ETT) at the agency for new packaging design for parenteral products.

Dr. Srinivasan received her Ph.D. in Pharmaceutical Sciences from the University of Connecticut (USA), Master’s in Biochemical Engineering, and Bachelor’s in Pharmacy (India). Her Doctoral research involved multi-disciplinary areas in formulation science; nanomaterials; bio-conjugation and high resolution imaging. She has received multiple awards for her Doctoral research. As a Post-Doctoral Associate at the Harvard Medical School and MIT, her research involved nanoparticle delivery in hard to transfect immune cells, cancer models and protein formulation science, prior to joining FDA.