Webinar Replay: Survey Reveals Many Regulatory Submissions Management Systems Are Not Future-Proofed

Nov 04, 2016

Recent webinar, polls reveal challenges and future plans in regulatory submission processes

Regulatory Webinar Replay

Deploying an efficient regulatory submissions management system is a challenge for many pharmaceutical companies as they wrestle with the vast amount of information exchanged within their own departments, affiliates and regulatory authorities. The process is often manual, labor-intensive, error-prone and inefficient – all of which can lead to delayed time to market, lost revenue and failed filing processes.

Despite having purchased solutions to help with the submissions process, the last leg tends to remain a largely manual process. Current systems do not address the electronic submission process to the health authorities, leaving companies stuck transmitting information in the required format(s) while maintaining an audit trail throughout the process.

DIA @ 2016

Top Challenges With Regulatory Submissions

It should come as no surprise that, on a recent webinar, many regulatory professionals cited time spent managing submissions, having a consolidated repository for their product portfolio, and collaboration with other groups as their top challenges:

RSMS challenges chart 1

What Are Your Plans for Addressing Future Challenges?

Further, while many recognize the need to improve their submissions processes, few have taken action to future-proof their submissions processes for upcoming initiatives like IDMP – and in fact, none of the respondents have implemented a solution to address future regulatory submissions processes:

Addressing Future Challenges chart

To gain more insights on regulatory submission challenges from insights from industy experts – including a Top 10 Pharma executive – watch the “Closing the Gaps in Regulatory Submission Processes” webinar today!