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New Product Development » New Product Development: Structure and Functions
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The successful development and launch of new combination products in a timely manner can provide a significant competitive advantage to biopharmaceutical organizations. However, stringent regulatory guidelines and manufacturing complexities are few of the major challenges in launching these new products.
Consequently, it is important to develop a strategic approach to external engagement to effectively navigate these challenges. In this study, “external engagement” refers to the activities and collaborations undertaken to help shape future combination-product standards and regulations.
Best Practices, LLC undertook this benchmarking research to inform product and leadership teams about key external engagement approaches, staffing and investment needed to successfully develop and launch combination product assets. This study also identifies companies that are considered to be industry leaders in shaping combination product regulatory requirements and the reasons for the same. The top post-marketing safety reporting challenges are also highlighted in this study.
Best Practices, LLC engaged 17 executives from 14 leading pharma, biotechnology and other healthcare companies in this research through a benchmarking survey.