We are a professional consulting firm providing a full range of services from consulting assessment and requirements through project management solution strategies, implementation and optimization. Xcellas provides lean alignment between business, engineering, quality, IT, tech services and manufacturing while maintaining overall governance and regulatory compliance. Xcellas is a minority owned business and we pride ourselves to be small enough to provide the upmost attention to our clients as well as to scale up to any demands of our clients without sacrificing the quality and experience of our team members to lead successful implementations. Governance, Regulatory & Compliance Services - Quality Management - 483/Consent Decree Remediation - Periodic Equipment/System & Facilities Reviews - Validation Master Plan - Gap/Risk Analysis and Assessment - Equipment, Facilities/Utilities Decommissioning - Test Methods Validation, Cleaning Validation, Computer System Validation, Process Validation - Qualification of Lab Equipment/Instrument/System Advisory Services - Business Case, and ROI - Program/Project Strategy Roadmaps - PMO Maturity Assessment - Organizational Change Management - Process Mapping & Optimization - Lean Six Sigma - Facilities & Utilities Commissioning and Qualification Engineering Services - Lean Program Execution - Commissioning New Manufacturing, Business and Laboratory Facilities - Program & Project Management - Construction Management - Engineering & GxP Capital Project - Developing and Testing New Product Lines - Technology Transfers - Quality Engineering IT Solutions - Application Portfolio Rationalization - Enterprise Information Management - Enterprise Portfolio Management - Information Governance - Application Development and Integration