Omar Mmubango: A Pro at Regulatory Compliance and Pre-Approval Facility Inspections

Filed under: Omar Mmubango — Wrote by admin @ 11:44 am

Omar Mmubango knows the pharmaceutical industry like the back of his hand. Having gained invaluable experience from working “in the trenches of the pharmaceutical industry,” Mr Mmubango is uniquely qualified to provide advice to companies with regard to regulatory compliance and pre-approval inspections for their facilities.

Omar Mmubango is widely considered an expert in the FDA’s pre-approval facility inspections. Among others, his responsibilities include preparing key documents such as SOPs, Validation and Stability protocols, determining batch and manufacturing procedures, and identifying key or critical areas in the facility likely to be inspected. He also advises key company departments and personnel or heads of key departments on the regulatory standards expected by the FDA and how best to comply with those requirements.

Omar Mmubango is also the founder of Regulatory Affairs CMC Resources Corporation (CMC Resources); and is often called upon for his expertise in assessing and evaluating how clinical trials are conducted.

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.

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