ANBLIK Weblog

Omar Mmubango is considered and expert at regulatory compliance for the USFDA. Over the years, he’s acquired considerable expertise in matters related to verifying whether or not pharmaceutical companies and manufacturers are strictly adhering to commitments they’ve made to the USFDA regarding their drug applications.

A professional through an through, Omar Mmubango uses his expertise to determine whether drug companies have made any changes to their drug formula, manufacturing process, or labeling which could have a bearing on the safety and effectiveness of drug products already approved by the FDA for the US market. He also ensures that any such changes made by drug companies are immediately reported to the FDA.

Omar Mmubango hard won expertise is the result of years spent in the trenches of the pharmaceutical industry, learning everything from the ground up. During his college years, he worked as a tablet machine operator and Quality Assurance (QA) tester. His internship was spent as a research associate supporting clinical trials. After college, he continued his education in pharmaceuticals as a bench chemist in the Quality Control (QC) Laboratory.

Professionally, he’s been a senior quality assurance auditor, responsible for, among other things: reviewing batch records, validation protocols, standard operating procedures, and internal controls checklists. He gravitated towards regulatory compliance, verifying FDA submissions and applications. In this capacity, he audits and edits CMC sections of drug application files or dossiers for accuracy and completeness, before such applications are submitted to the FDA.

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.