Omar Mmubango: A Proven Expert in Regulatory Affairs Compliance Standard Operating Procedures
Omar Mmubango gained his expertise in regulatory compliance from trenches of the pharmaceutical industry.
His hard won practical knowledge is the result of years learning everything from the ground up. To illustrate, during his college years, he worked as a tablet machine operator and Quality Assurance (QA) tester. He worked as a research associate supporting clinical trials during his internship. After graduating from college, he continued his training in the pharmaceutical industry as a bench chemist in a Quality Control (QC) Laboratory.
Now an independent businessman, Omar Mmubango is the founder of Regulatory Affairs CMC Resources Corporation (CMC Resources,) a company that provides short and long term resources and services related to regulatory compliance within the pharmaceutical industry.
Omar Mmubango work often calls on him to formulate, review, write and implement standard operating procedures. These are then used by both the Regulatory Affairs—CMC and Regulatory Compliance groups in reviewing, editing, auditing and writing of the FDA drug applications. CMC refers to “Chemistry, Manufacturing and Control,” and refers to the process by which the production of a drug is optimized so that it can be produced in larger volumes.
He is extremely well versed in requirements for FDA submissions such as: Investigational New Drug Application (INDA), New Drug Approval (NDA), Biologic License Application (BLA) and Abbreviated New Drug Application (ANDA), including all supplements and amendments.
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.
