For CDMOs & CMOs
Your partner for overflow, specialty, and next-step work.
Don’t turn clients away. Channel overflow when you’re at capacity, subcontract specialized steps like ISO 5 aseptic processing or lyophilization, or refer clients whose next phase sits outside your scope.
The challenge
Sound familiar?
- Turning away work when you’re at capacity
- Client requests outside your specialty
- Clients whose next phase outgrows your scope
- Building niche capability for a handful of programs
How the platform helps
- White-label and subcontract arrangements
- Specialized human tissue (HCT/P) processing experience
- Referral partnerships that protect your client relationships
- Commercialization services you can offer your clients
Typical engagements
Use one service, or the whole platform.
Place work with us when your schedule is full.
Hand off specific steps such as ISO 5 processing or freeze-drying.
Refer clients for services you don’t offer.
Connect clients to our sales and distribution channels.
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.