With roots in research and manufacturing of complex biologics, and decades spent honing our regulatory and operational expertise, we deftly navigate development milestones throughout the entire product lifecycle.

Our high-performing teams have a proven track record of success in delivering innovative solutions and large volumes of quality work product, on time and within budget.

Having guided assets from candidate selection through commercialization, we know how to avoid the perils in your regulatory journey. We implement best practices, leverage our lines of sight, and formulate creative solutions to
your program's unique challenges.

We love what we do and new learnings are never in short supply.

Few things give us greater joy than knowing we were instrumental in bringing a new treatment to market or in helping a new start-up receive its first Safe-to-Proceed.