In the conditions of high regulatory and market uncertainty, export of medicines to the European Union (EU) requires flexible approaches to project management. This paper examines the possibility of applying Agile methodology, traditionally used in IT, to a project to enter the pharmaceutical market in Bulgaria. In this work case-oriented scenario is presented for the export preparation, where tasks divided into iterations (sprints) with the descriptions of the key roles and advantages of applying of flexible management. The article demonstrates the practical value of the Agile approach in the context of constantly changing regulatory requirements and a high degree of cross-functional cooperation.