Omar Mmubango Uses his Expertise in Scale-Up and Commercial Manufacturing

Omar Mmubango is the founder of a company called founded Regulatory Affairs CMC Resources Corporation (CMC Resources). It is his business to provide short and long term resources and services related to regulatory compliance within the pharmaceutical industry.

Among the many services Omar Mmubango provides his clients: review data utilized in Scale-Up or Large-Scale commercial manufacturing of FDA regulated pharmaceutical drug products intended for human consumption. This is a necessary process that drug companies undergo before and after data has been submitted to the FDA for approval. It is meant to ensure the completeness, accuracy, and above all, compliance of manufacturers with the FDA’s and ICH’s regulations, standards and guidelines
Based on his extensive knowledge in the FDA’s regulatory approval processes, Omar Mmubango can make recommendations to pharmaceutical companies and ensure their compliance with FDA regulations.

He is also adept at other FDA applications processes 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.