Prototyping is an increasingly valuable yet inconsistently applied practice in regulatory writing. By strategically developing a detailed and internally approved draft of each sub mission document early in the process (pre-data), teams can improve clarity, accelerate timelines, and gain a competitive advantage. However, there are also barriers to adoption of this practice, centred in team culture and a hesitation to change past ways of working. A shared understanding of what constitutes a robust prototype and understanding how to overcome the barriers is essential to successfully integrate prototyping into routine submission planning.