Contract Manufacturing
SokoLife is an ISO 13485:2016-certified developer and contract manufacturer of bovine pericardium-derived materials, supporting partners from concept through scale-up and regulatory submission.
Transform Your Tissue-Engineering Project
Our team supports the transition from laboratory bench scale to commercial production under a certified quality management system. Partners retain full ownership of their developed products.
Services
- Feasibility & proof-of-concept studies - assessing viability for further development
- Product development - from concept through final realization
- Process development & scale-up - bench-to-commercial manufacturing
- Material characterization & device testing - performance and durability evaluation
- Regulatory documentation support - material data and traceability for submissions
Capabilities
- Decellularization and ECM processing
- Glutaraldehyde fixation
- Custom sizing and packaging
- Sterilization coordination (e-beam / gamma)
- Study and protocol design support
- Comprehensive reporting for regulatory submissions
Quality & Compliance
- ISO 13485:2016-certified quality management system
- Closed-herd, USDA-sourced bovine tissue (ISO 22442-2:2020)
- TAA/BAA-compliant supply chain with full material traceability
SokoLife provides contract development and manufacturing services. Products and materials produced are subject to applicable regulatory requirements; SokoLife's own pipeline products are investigational and not cleared or approved by the FDA for clinical sale in the United States.