With roots in analytical research and manufacturing, and decades spent honing our regulatory expertise, our consultants
and strategic partners deftly navigate development milestones at the technical
and regulatory interface that is CMC.

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

We have spent our entire careers in CMC, because 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 patients or in helping a new start-up receive its first Safe-to-Proceed.