Article | January 17, 2025

Successful Regulatory Submission Via The Trifecta Of Awesomeness

GettyImages-1398569507 regulatory

It is common for contract research organizations to assume that, because they have completed numerous regulatory submissions, they know what a “good” one looks like and can start right away. But three essential elements contribute to a repeatable, adaptable submission process: strategic planning, team engagement, and properly leveraging team experience.

Strategically planning medical writing means fewer rewrites, higher document quality, and greater likelihood of a successful submission — versus delays, lower document quality, rework, and a frustrated team. Team engagement hinges on shared values, clear expectations, and fluid communication. Regarding team experience, time in industry and the number of submissions a team or individual has handled are broadly recognized as indicative of submission experience. But experience is only as valid as the organized practices or skills it begets. Therefore, it is vital that submission teams be well-prepared, and organized to be capable of handling obstacles in their path.

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