Omar MMubango Information

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.