Alifiya Ghadiali has 10+ years regulatory experience at the US Food and Drug Administration with expertise in sterility assurance and microbial quality assessments of drug, biologic and medical device submissions including BLA, EUA, NDA, ANDA, PMA, 510(k), HDE, IND, IDE, master files and meeting packages. She has experience in pre-license and pre-approval inspection of cell and gene therapy, vaccine and other biologics manufacturing facilities.
Alifiya Ghadiali has served in various roles at the US FDA since 2011 at CBER, ORA (now OII), CDER and CFSAN. She earned her bachelor’s and master’s degrees from the University of Mumbai, India, doctorate degree from The Ohio State University and performed post-doctoral research at the University of Medicine and Dentistry of New Jersey (now Rutgers). She also holds Regulatory Affairs Certifications in Drugs and Devices.