For emerging companies
Launch without building a plant.
Get cleanrooms, a documented quality system, experienced staff, and a commercial channel on day one. Take only what you need now, and add services as your product matures.
The challenge
Sound familiar?
- Facility capital required before revenue
- Hiring production and quality teams from scratch
- Navigating regulatory requirements for the first time
- Finding a credible channel to market
How the platform helps
- Preserve capital for science and growth
- Stage-gated programs from concept to launch
- Access to operators who have launched regulated products themselves
- One partner from development to distribution
Typical engagements
Use one service, or the whole platform.
Development, production and commercialization in one plan.
Feasibility, formulation and pilot batches.
Ongoing manufacturing as you scale.
Launch, sales and distribution 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.