Omar MMubango, aside from being a known expert when it comes to Regulatory Affairs, is also a celebrated professional when it comes to utilizing Scale-Up or Large-Scale commercial manufacturing of the FDA or the Food and Drug Administration.

Large-Scale or Scale-Up commercial manufacturing is aimed at extending the manufacturing processes, starting from bench-scale experimentation until finally transferring to large-scale commercial manufacturing of new drug products.

The bench-scale trialing was done to explain how the transition occurs via various scale-up iterations, toxicology studies and clinical trials. This way, every single detail related to the drug is documented so that drug inconsistencies are avoided.

It is Omar MMubango who assesses the information and data provided completely before the information is then submitted to the FDA. The FDA will then assess the drug product’s information for accuracy and completeness.

Also, it is within Omar MMubango’s duty to make sure that the drug manufacturers strictly comply with the rules and regulations of the FDA and also of the International Conference on Harmonization (ICH).

There are standards and guidelines that drug manufacturers need to strictly adhere to so that their drugs will be approved for sale and marketing to the public. Having even just one inconsistency with the drug’s details and its documentation will be detrimental to its release to the public.

Whenever discrepancies are spotted, Omar MMubango steps right in and makes use of his expertise to initiate the necessary changes in the pharmaceutical’s information.