We deliver clinical builds and small batch manufacturing for companies developing products that require clinical trials and pilot production. With flexible small batch manufacturing and specialized regulatory support for device-led combination products, we help bring life-saving medical innovations to market.
Our innovation-driven approach as an end-to-end CDMO partner enables efficient progression through clinical development and a reliable, high-precision transition to commercial manufacturing, from first-in-human trials to scale-up planning.
With a proven track record of supporting clinical trials, we offer flexible manufacturing for combination products including autoinjectors, pen injectors, pre-filled syringes, and inhalers. Over the last two decades, our team has supported hundreds of combination products on their path to market.
Our sites specialize in medical device assembly, testing, and packaging, supporting design validation builds, clinical production, and new product introduction. They feature on-site ISO Class 7 and 8 cleanrooms. When your product is ready to scale, additional capacity across our global network supports a seamless transition to high-volume production.
Our clinical manufacturing sites are FDA-registered, ISO 13485 certified, and cGMP-compliant, with quality systems that support combination products and rigorous product validation under FDA 21 CFR Part 4. Complete documentation and full traceability keep every batch audit-ready.
End-to-end development and manufacturing for a product that helps surgeons collect and use bone for grafting.
Accelerating the time to market for a novel ophthalmic implant drug.
Designing and manufacturing a hands-free hemostasis device that stops bleeding without stopping blood flow.
