Omar Mmubango Regulatory Compliance, Reviewing and Editing

Posted by admin on June 8th, 2009

Omar MMubango is an expert in reviewing and editing FDA Regulatory submission applications on CMC issues, ensuring not only that such documents are through, complete and accurate, but also contain no puffery before they are submitted to the FDA and U.S. government. With his profession, He really gives a huge impact towards Pharmaceutical Industry. He gives the aid and knowledge on what is relevant to make an improvement and enhancement on the industry of pharmaceuticals. With his profession, you can see that he really does everything making more innovations towards improvement but that is not his only achievements in life. He is also a humanitarian in nature and an environmentalist over pollution problem.

He is a true gentleman, he can make things possible in every way through is work, helping his fellowmen, and being aware on the environment.  He really treasures this craft. A man full of dreams and able those dreams to be past on to make things more brighter and more fulfilling to every individual. He is the bridge that binds together all the things he want to have. The change that he looks for the future and more brighter for everybody and especially with his community. He creates more opportunities for most individual locally and across the globe.

Equipped to do Personnel Training

Posted by admin on May 8th, 2009

He  provides excellent in-house employee training in the areas of Chemistry, Manufacturing and Controls to Regulatory Affairs—CMC personnel.  It seems that he is in a league of his own when it comes to his expertise in devising, amending and writing the Standard of Operating Procedures (SOPs) of the Regulatory Affairs. He has the ability to offer the most inclusive short course option for the CMC training professionals wherein his combined years of present industry knowledge along with a supreme capability to carry out information in a comprehensive and concise manner can really prepare the trainees in this field.

Furthermore, he makes it a point to stay on top of things just to make sure that the standardized procedures and languages are adhered and utilized by all CMC reviewers of drug application documents at all times. He has crafted and designed an effective program for personnel who are involved in the preparation of “Chemistry, Manufacturing and Controls” (CMC) section of a NDA or IND; however, for those personnel who are not part of the CMC document preparation but fancies an overall insight of what is involved for both the drug substance and drug product, his insights will definitely aid them as well.


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