Quality & Compliance
We'd rather tell you upfront what our quality level covers, and what it doesn't, than have it come up as a surprise halfway through your project.
Our quality processes are built around ISO 13485 principles, applied at a scale that fits pilot and feasibility work.
Our equipment and processes are designed for feasibility, pilot, and early-stage production — not high-volume commercial manufacturing.
Our lyophilization process isn't formally validated for sterility assurance on its own. What we offer instead: on request, a completed batch is sent to an independent, accredited third-party laboratory for sterility testing — with results shared with you directly, batch by batch.
Tell us what you're building and what it needs to comply with — we'll tell you plainly if we're the right fit.
Ask Us Directly