Bringing treatments to patients with rare diseases has long been one of the biggest challenges in drug development. With small patient populations and complex regulatory hurdles, getting a therapy approved requires strategic expertise, innovation, and deep collaboration with regulatory agencies.
In this expert video, Steve Sibley, BS, MS shares firsthand insights into how regulatory submissions shape the future of rare disease treatments—and how the landscape has evolved to better support drug development.
Certara’s regulatory writing team has supported 110+ rare disease submissions across 70+ unique conditions, helping to secure approvals worldwide.
