When it comes to your program’s success, there is no room for compromise. Quality runs through every decision, process, and interaction.
Because what we build today shapes the trust we earn tomorrow. With EU-GMP approvals already secured, and FDA approval in place for drug substance manufacturing, we offer a solid foundation you can build on, without pause or second-guessing.
From day one, we anticipate potential roadblocks early, so you can plan with greater confidence and fewer surprises. Our proven, inspection-ready European sites help de-risk your program and strengthen your regulatory strategy, setting the stage for long-term success.
Adhering to the highest international standards, you can count on every batch we deliver. With EU-GMP for all GMP sites, and FDA approval for our drug substance manufacturing already in place, you can progress without pause. What we build today isn’t just a product, but it’s a partnership and trust for the long term.
With clear data and documentation always at your fingertips, you’ll always know where things stand. We keep things clear and audit-ready, not just for the regulators, but so you and your team are kept in the loop.
By embedding quality thinking at every level of our organization, we uphold your standards even when the pressure is on. Our proactive approach means fewer fires to fight and more forward momentum for your project.
To us, every molecule, every milestone, and every moment matters, because Right First Time is all in the details. This core principle guides how we operate, how we solve problems, and how we protect your timeline and outcomes.
We hold a number of quality certificates, including GMP, FDA, FAMI-QS, Ecovadis and more.
