Launching new products is a critical process for firms, especially in the life sciences sector, where different institutional environments must be considered. Despite the importance of the health sector, there is a lack of research on the new product launch process in the life sciences and the impact of national contexts on this process. This study used a case study approach to explore the launch process of a multinational enterprise across multiple countries. Thematic analysis of interviews with key employees from over 20 countries provided a framework for the challenges and legitimating strategies used in new product launches worldwide. We argue that new product launches are shaped by different factors across countries, with some patterns rising from emerging and developed countries. This study offers valuable insights for both theoretical and practical perspectives, as it contributes to the literature on new product launches by examining how different institutional settings influence the process. Additionally, this study includes institutional and legitimation theory, which provides useful theoretical angles for understanding international new product launches in the life science industry. Finally, the paper provides empirical evidence for the diffusion theory on the factors influencing the launch process of new products in the life science industry.