Specialized Consulting Services for cGMP Cellular Therapy Laboratory

The University of New Mexico is seeking specialized consulting services to support the planning, design, regulatory compliance, validation planning, and operational readiness of a state-of-the-art cGMP Cellular Therapy Laboratory and associated Clinical Trials and Hematology support spaces. The services include regulatory design review, risk analysis, development of a Master Validation Plan, User Requirements Specifications (URS), SOP support, and guidance to achieve licensure and accreditation readiness. The contractor will provide unique expertise and experience not available from general consulting firms. • Specialized consulting services for cGMP cellular therapy laboratories • Regulatory integration and validation planning • Licensure readiness and accreditation support • Project-specific regulatory and design knowledge • Unique expertise and experience in cGMP cellular therapy laboratories