For international companies
Produce in the United States — and sell here, too.
Domestic production can simplify U.S. regulatory pathways, reduce trade and tariff exposure, and shorten supply chains. Transfer your process to Salt Lake City and use our commercial team to reach U.S. customers.
The challenge
Sound familiar?
- Tariffs and trade uncertainty on imported products
- Meeting U.S. regulatory expectations from abroad
- Long and fragile international supply chains
- No established U.S. commercial presence
How the platform helps
- U.S.-based production and quality release
- A team experienced with FDA requirements
- Technology transfer support into our facility
- A ready-made U.S. sales and distribution channel
Typical engagements
Use one service, or the whole platform.
Bring your process into our facility and quality system.
Produce in the U.S. for the U.S. market.
Guidance on applicable U.S. requirements.
Sales, distribution and market-access support.
Why Levaris
Proven on our own regulated products.
We built this platform to develop, manufacture and commercialize the DermaBind® family of human tissue-based products. The cleanrooms are running, the team is trained and the channels are live.
About LevarisISO 13485
Quality management system aligned with ISO 13485, the medical-device quality standard.
ISO 7 / ISO 8
Classified modular cleanrooms with controlled material and personnel flow.
ISO 5
Biosafety cabinets for aseptic, open-product processing.
21 CFR 1271
Processes designed to meet applicable FDA requirements for HCT/Ps.
How it works
From first conversation to first batch.
- 01
Discovery call
Tell us about your product, stage and goals. We sign an NDA before any technical detail is shared.
- 02
Technical & quality fit
Our scientists and quality team assess your process, materials and regulatory path — then propose a scope.
- 03
Transfer & qualification
We bring your process into our facility and quality system, with documented qualification runs.
- 04
Production & launch
Ongoing manufacturing and release — and, if you choose, sales and distribution through our commercial channels.
Tell us what you’re building.
We’ll respond to schedule a confidential discovery call — or an in-person or virtual tour of the Salt Lake City facility.