Proactive Renewal Management: The Key to Cost Savings and Regulatory Efficiency

Author: Karen Cohn, Director, Regulatory Strategy

For medtech regulatory affairs (RA) professionals, one crucial aspect of their job is managing product renewals to maintain regulatory compliance in various regions around the globe. With hundreds or even thousands of registrations across different markets, each with its own renewal cycle ranging from three, five, or even 10 years from their approved date, the task of proactively managing renewals can be daunting and error-prone.

Challenges with traditional renewal management

Traditional renewal management practices often rely on siloed data stored in various systems and spreadsheets across the organization. In a recent regulatory benchmark study, 69% of participants reported that they had no alert system in place for license expirations or the alerts weren’t specific to individual renewals. This fragmented approach makes it difficult to obtain a comprehensive overview of renewal dates, increases the risk of missed deadlines, and results in potential product delays. Moreover, notifications regarding upcoming renewals often arrive late, leaving RA teams scrambling to catch up. 

This disjointed process may also overlook the input of sales teams. Sales people have valuable insights into product demand and market trends, which can inform decisions on whether to renew or discontinue certain products. Without this collaboration, RA teams may invest time and resources on renewals for products that are no longer aligned with market demand.

Benefits of proactive renewal management

Proactive renewal management offers a strategic approach to managing product renewals, bringing efficiency and cost savings to the RA process. By implementing proactive measures, companies can reap several benefits:

  • Reduced costs by avoiding product delays: Staying on top of renewals allows companies to minimize product delays, lost sales, and customer dissatisfaction. It also eliminates the need to apply for a brand new registration, which can be a lengthy process once a product passes its expiration date.
  • Proper obsolescence management: With visibility into which products are close to their end of life, RA teams can strategically pick a date that works within the registration expiration period and makes sense globally.
  • Enhanced collaboration with sales teams: Integrating sales insights into renewal decisions ensures that RA teams focus their efforts on renewing products with continued market demand. This collaboration can lead to cost savings by avoiding unnecessary renewals and freeing up RA resources for higher-priority tasks.

Implementing proactive renewal management

When adopting a proactive approach to renewal management consider these few key steps:

  1. Establish a single source of truth for regulatory information: Consolidating regulatory information into a centralized repository provides a clear and comprehensive overview of renewal dates and product status.
  2. Implement a renewal tracking system with automated reminders: A robust tracking system automates the process of monitoring renewal dates and sends timely reminders so RA teams can plan accordingly.
  3. Collaborate with sales teams to identify products for non-renewal: Regular discussions with the sales team help identify products that are no longer aligned with market demand or have declining sales figures. This collaboration streamlines the renewal process by focusing resources on products with continued market relevance.

To learn more about how a single source of truth can streamline renewal management and the entire end-to-end regulatory lifecycle, read this feature brief for Veeva Registrations.