Services
Contract Manufacturing
An Experienced Manufacturer of Rapid Diagnostic Products
We currently produce a wide variety of Point-of-Care diagnostics, including lateral-flow assays, flow-through tests, and microplate-based tests.
Our primary manufacturing site is located in Las Cruces New Mexico. Palladium have established a full-scale contract manufacturing capability with environmentally controlled assembly processes. We utilize a full range of manufacturing equipment capable of handling production volumes ranging into the million+ test per year range.
Our Capabilities
From Small-volume to Large-Scale Production, Palladium's Highly Flexible Manufacturing Solutions Can Meet Any Need
- Full lateral-flow production capabilities
- In-house gold colloid manufacture
- Full packaging solutions including kitting & boxing
- Bottle & tube filling, capping, & labelling
- Manufacturing process design & optimization
- Full conjugation capabilities, passive & covalent chemistries
- Transfer to manufacturing and product commercialization assistance
- Risk analysis
- Verification and Validation of manufacturing processes, procedures, and protocols
- ISO 13485, IVDR, 21 CFR 820 Compliant
- Facility and vendor audits
Small and Large Volume Manufacturing
Palladium Diagnostics has a facility capable of producing any scale lot, from pilot batches through commerical scale volumes.
Quality and Regulatory Support for Your Products
Our manufacturing team has extensive experience working in cGMP and heavily regulated markets. Palladium has integrated quality and regulatory systems into manufacutring processes to support manufacturing compliance.