At Yourgene Health we have a global team with extensive expertise, skills and industry knowledge spanning from non-regulated to highly regulated IVD manufacture and kitting capabilities. We operate to GMP standards with best in practice quality control procedures to ensure high quality, robust and reproducible assays. We provide excellent logistics support to overcome regulatory hurdles, enabling product availability worldwide.
Yourgene is able to make use of its state-of-the-art manufacturing facility at Citylabs in Manchester, UK, to fulfil contracts.
Key features of Yourgene Health’s contract manufacturing capabilities:
- We employ OTIF (On Time In Full) metrics to ensure the right product gets to the right customer on time
- We have global market access through established logistics channels
- Adherence to ISO13485 quality management system
- Lean / 5S manufacturing principles
- Currently manufacture 30+ products including NGS and PCR products
- Dedicated experienced QC team
- GMP compliant Manufacturer of IVD and RUO reagents (ISO13485)
- Extensive experience with >25 years with majority of molecular diagnostic suppliers