Omar Mmubango is no stranger to FDA Submissions

While many drug companies struggle with FDA submissions, Omar Mmubango is no stranger to FDA applications.

Omar Mmubango has considerable expertise in coordinating the compilation, writing and filing of the FDA’s drug applications. These encompass submissions for Investigational New Drug Application (INDA), New Drug Approval (NDA), Biologic License Application (BLA) and Abbreviated New Drug Application (ANDA), including supplements and amendments. He is knows exactly what to do if post approval changes are required and is adept at implementing comparability protocols. This combination of skills and know-how have allowed his company Regulatory Affairs CMC Resources Corporation (CMC Resources), to provide short and long term services related to Regulatory Affairs in the Pharmaceutical Industry.

Omar Mmubango also has considerable experience in different internal source areas, as well as liaising with domestic and International regulatory agencies, setting regulatory submissions time lines, and ensuring that all drug projects are proceeding in accordance with all applicable FDA, International Conference on Harmonization’s (ICH) regulations, standards and guidelines.
Omar Mmubango graduated from the University of Minnesota where he earned a B.Sc. in Chemistry as well as a BA Public Health-Affairs. He also has a B.Sc. in Agricultural Sciences—Food Science & Technology from the University of Wisconsin.