Omar Mmubango, a man who is proud to have learned what he knows from “the trenches of the pharmaceutical industry” (as he likes to put it) is an expert in conducting Good Clinical Practice (GCP) audits.  As founder of Regulatory Affairs CMC Resources Corporation (CMC Resources), Mr Mmubango is often called upon for his expertise in assessing and evaluating how clinical trials are conducted

Quality Assurance can be periodic, quarterly or for cause. Omar Mmubango evaluation of  GCP Quality Assurance and Regulatory Compliance, includes but  is not limited to Trials Master Files auditing, generating lists of violations or observations, discussing such observations with supervisors, managers of laboratories or the  principal director of research and recommending corrective actions and remedies.

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

Professionally, he gravitated towards regulatory compliance, verifying FDA submissions and applications. Throughout his career, he has audited and edited CMC sections of drug application files or dossiers for accuracy and completeness, before such applications were 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.

Omar Mmubango is the founder of Regulatory Affairs CMC Resources Corporation, a company which provides short and long term resources and services related to Regulatory Affairs in the Pharmaceutical Industry.

Through his many years in the pharmaceutical industry, Omar Mmubango has gained considerable expertise in coordinating the compilation, writing and filing of FDA drug applications. Whether an application involves Investigational New Drug Application (INDA), New Drug Approval (NDA), Biologic License Application (BLA) and Abbreviated New Drug Application (ANDA), Omar Mmubango has the practical and technical knowledge to see projects through.

Omar Mmubango is also considered an expert in FDA regulation 21 otherwise known as Code of Federal Regulations Part 11 or simply “Part 11,” which deals with FDA guidelines on electronic records and electronic signatures in the United States.

Part 11, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to conventional paper records. In practical terms, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries (with specific exceptions,) to implement controls, which include audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule.
Mr 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.