New Publication: Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight
We’re proud to share that Orbit team members Kevin Fetterman and Christopher Long have co-authored a newly published article in Therapeutic Innovation & Regulatory Science, in collaboration with experts from Takeda and Axian Consulting.
“Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight” explores the need for structured, scalable systems to track global and local risk management activities including RMPs and additional risk minimisation measures (aRMMs).
Drawing on real-world implementation experience, the article highlights how purpose-built software like Orbit can replace fragmented, manual processes with efficient, auditable workflows—helping organisations align with evolving regulatory expectations while improving cross-functional collaboration.
Read the full article here: https://link.springer.com/article/10.1007/s43441-025-00825-8
