Q: Is your team simply writing a dossier, or are they following a clear strategy?
A: The most effective teams do both, but strategy should come first. Preparing a submission package entails developing a detailed project plan and adopting a well-coordinated strategy to usher a dossier through the various stages of compilation, review, quality control, editing, and completion. 

Success in preparing a dossier for submission to regulators hinges on the approach the writing team takes, including how they plan, communicate, coordinate, and resolve differences. In other words, their leadership and project management skills are every bit as critical as their ability to communicate clearly, conclusively, and impartially. The Need for Leadership at Multiple Levels The complexity of preparing a regulatory submission calls for strong leadership across multiple levels to ensure that deadlines are met, divergent views explored, quality issues resolved, and resources allotted efficiently. Otherwise, there is a risk that the project can be derailed, delaying submission and ultimately, product availability for patients.