For established companies
Add capacity without adding a facility.
Outsource a product line, a process step, or a development program to a team already running at a regulated standard — and keep your own capacity focused on your core products.
The challenge
Sound familiar?
- Your own lines are at or near capacity
- A new product doesn’t justify building a new suite
- One program needs capabilities you don’t have in-house
- Capital is better spent on pipeline than plant
How the platform helps
- Dedicated cleanroom time and trained staff
- Your specifications, run inside our documented quality system
- ISO 5 aseptic processing and lyophilization on site
- Optional U.S. sales and distribution support
Typical engagements
Use one service, or the whole platform.
We produce your product to your specifications.
Reserve cleanroom and equipment time on a schedule.
Extend your lab capacity during peaks.
Move an existing product or process into our facility.
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.