Omar MMubango Information

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.

Omar is an expert in coordinating the compilation, writing and filing of the FDA’s drug applications or INDA, NDA, BLA and ANDA, including supplements and amendments  He is an expert in working with different internal source areas, as well as liaising with domestic and International Regulatory agencies setting Regulatory submissions time lines, and ensuring that all drug projects proceeding in accordance with all applicable FDA, International Conference on Harmonization’s (ICH) regulations, standards and guidelines.

He never forgets his dedication and commitment towards his profession he want to see to it that he could balance everything through his career and his humanitarian as well as being an environmental awared. This is not an easy mission to do, but this is what he loves on doing what is right and able to follow the compliance through its regulations, standards and guidelines.

With his wide ranging expertise and knowledge of FDA and Pharmaceutical Industry, he really make use to it that he could be able to make the world of Pharmaceutical to be improve and revitalized with his help and knowledge about it. He could share his facts and opinion on his part as a Pharmaceutical Executive. He hasn’t been an Executive with his determination and love of his career.

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.

He is a proven expert in Regulatory Compliance. This type of program centers on the verification of commitment pharmaceutical companies make to the FDA through drug applications or INDA, NDA, BLA, and ANDA submission documents.   This is done to ensure  that pharmaceutical companies strictly adhere to the commitment they make to the FDA and U.S. government—particularly on the issue of drug safety and efficacy.

He is an expert in ensuring that, if there changes with the commitments pharmaceuticals companies make to the FDA during drug applications – whether in drug formula, manufacturing process, labeling, or if any change is made on any CMC issues pertaining to the already approved drug products, which might  be an impact Safety and Effectiveness of drug products that such changes are reported to the FDA, and the corresponding drug applications (INDA, NDA, BLA, and ANDA) are updated to reflect such changes in a timely manner.