ABSTRACT
The knowledge of the goal, the order of various events, uncertainty around those events and possible plan to mitigate or deal with the uncertainty are essential for the development of any strategy. The strategy provides the path to deliver the economic growth and the contribution it plans to bring to its patients, its shareholders, customers, and society at large. Planning a good strategy is significant because it is not possible to foresee the future. Regulatory strategy is a plan of action designed to achieve a specific regulatory goal, such as to obtain marketing approval for drugs, biologics, and medical devices and ensuring the approval of products complies with the laws and regulations of the countries where they are marketed. A regulatory strategy as a formal document helps to align the regulatory activities, together with the business strategy, to bring a new or modified product to market.
