We provide pharmaceutical companies with the regulatory packages required to win drug approvals. In general, our team strictly adheres to the guidelines of the United States Food and Drug Administration for approval of medicinal products. Packages and submissions are customized to the requirements of specific regulatory bodies.
Dr. Negida has previously provided several submission packages for major pharmaceutical companies in the MENA region including submissions to the Saudi FDA. The manager of the regulatory affairs department, Dr. Hussien Ahmed, has earned a master’s degree in regulatory science from the United States.
Over the past years, our team has developed winning strategies to obtain drug approvals from regulatory bodies. Please, note that before accepting to work on your regulatory package, our team runs an initial assessment to determine whether the evidence published in the literature and the unpublished data provided by the sponsoring company establish the safety efficacy and market need for the drug.