naga manju harshini pulibandla

United States of America

About Me

Hello, I'm Manju, currently a graduate student at Northeastern University. I hold a Pharm.D. degree from Dayananda Sagar University, where I completed a yearlong internship in a hospital and then trained there as a clinical research pharmacist.My educational journey has equipped me with a strong foundation in pharmaceutical sciences, and my internship experience allowed me to apply my knowledge in real clinical settings. During my masters,I reviewed and Analyzed: F.D.A. Regulations, ICH E6 and E8 Guidelines, Quality Assurance, Document Control, CMC, IND, NDA, ANDA, GLP, GMP, Clinical Trials, CFR Title 21, Informed Consent Form, GCP, IRB Study Protocols, Study Protocol Amendments, SOP, Preparation of Annual Reports, Safety Reports, Risk Analysis, Labeling and Advertising, Commercialization Strategies, PDUFA, FDA Guidance Documents, Clinical Protocols.

Overview