A Regulatory Leader’s Initiative to Streamline Submission Generation Using AI

A regulatory leader of an image-guided therapeutic business unit of a large medtech company was dissatisfied with the slow speed at which his global team was preparing submissions. It took the team an average of 8 to 10 months per submission. The business objective was to prepare 1200 – 1500 submissions per year. However, the probability of achieving these business goals seemed unrealistic at the rate at which the team was operating. Moreover, the pressure of transitioning to MDR added to the team’s stress. The US-based team was responsible for US, EU, and Canada submissions. Those were prepared manually by regulatory associates. A single regulatory associate could only prepare 4-5 submissions per year. The team would require tens of RA associates at a cost of over a million dollars to accomplish their goals. The international team was tasked with supporting distributors and channel partners across the globe to prepare submissions in respective countries. The team used emails to communicate and manage document exchange and correspondences with these external partners, contributing to additional delays and reduced submission preparation.

The regulatory team was seeking creative ways to prepare and manage submission generation.
Their objectives were to:

The regulatory leader was most impressed by RegDesk’s AI Submission Generator capability. It helped that the leader was a visionary and an early adopter of technology. He had envisioned a solution that would allow his team to use the work that was already done by an associate to be automatically used towards other submissions. He acknowledged that RegDesk’s AI technology would allow the content, whether that is data or attachments from one submission, to be auto-populated into subsequent submissions. The submission generation would automatically initiate tracking for that submission in RegDesk’s Tracking & Reporting module. The connectivity of all the modules of RegDesk was also highly appealing to the leader and his team. Furthermore, the leader was highly impressed by RegDesk’s customer service, the swift response to questions, the speed at which RegDesk developed additional configurations for the RA team, and the openness to feedback. The leader says that RegDesk has been one of the best vendors he has ever worked with in the 40+ years of his tenure in corporate.

The RA team saw excellent results through the AI submission generator. Instead of 8-10 months to prepare a submission, the RA associates were able to prepare a single submission within a week. The standardization of templates reduced the re-work. Once the US team prepares the initial submission, they are no longer required to share documents for that submission with the regional teams. The international team can immediately leverage the prepared submissions to create submissions for their respective countries using AI. They can render or share the submissions directly with economic partners through the RegDesk platform. RegDesk’s AI Submission Generator has saved the RA leader a million dollars in additional resources, reduced time to prepare submissions by months, and eliminated unnecessary redundancy of work among the team in gathering and sharing documents. The RA leader is an advocate for RegDesk.