Working closely to address client needs, Lifescience Business Solutions has supported numerous med-tech organizations in defining, implementing, and optimizing Quality Management Systems to ensure GMP compliance with current domestic and global industry standards for medical device manufacturing. We take an active approach thru assessment and consensus to link product innovation and downstream development with early adoption of Design Control benchmarks, process controls and accountability to ensure ease of design transfer, validation, regulatory compliance and organizational effectiveness. This not only mitigates strategic risks but also facilitates sound regulatory review and approval of submissions to position “design for manufacturability” and “cost of quality” for added value. Clients facing operational compliance challenges benefit significantly from our direct experience and hands-on capabilities to ensure effective closure to 483 observations, warning letters or consent decree injunctions. At Lifescience Business Solutions, every engagement subject to GMP regulatory guidance advocates a QUALITY philosophy that transforms end-to-end cultures through proven process excellence and quality ownership.