Colorado Lagniappe has the expertise required to perform the critical technology transfer activities, ensuring careful documentation and clear communication between cross-functional development and manufacturing teams. We can develop a technology transfer plan which identifies value-add activities, establish cross-functional transition teams with representation from both send and receive sites, identify handoff points, formulated responsibilities and formalized performance measurement — ultimately leading to enhanced quality performance as well as meeting aggressive production goals for your products.
- GxP gap assessments to determine audit-readiness.
- Audit/revise development and validation documentation.
- Review technical documents to support technical transfers and ensure commercial readiness.
- Training of personnel on equipment, procedures, and manufacturing processes.
- Root cause analysis to aid in CAPA investigations and process optimization.
- Provide technical expertise and support for sustaining commercial manufacturing operations.
- Process assessments for optimization opportunities utilizing lean six sigma principles.