During the definition phase, the IND is developed and submitted to the FDA, and the Phase I dose- ranging study is designed, so that, once the IND is approved, the study can immediately begin. Collaborative teamwork and workflow processes dramatically increase to support the initial drug filing and prepare for subsequent studies. A number of teams within the company (such as discovery and development research, regulatory, manufacturing, business development, and quality) work together to align FDA approval strategies and support effective go / no go decisions for senior management. The legal department, which is responsible for patents, is also highly engaged and must be immediately informed of decisions and changes. A secure, web-based, document management system for providing data and customized reports in real time can have a huge impact on the success of the company during the product definition phase.
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