A PROVEN PARTNER TO ENSURE REGULATORY COMPLIANCEThe engagement of an experienced partner is critical to successful product development and Advanced Clinical offers a full range of consulting and staffing services to support a variety of quality and validation initiatives.QUALITYAdvanced Clinical recognizes that demonstrating compliance with regulatory requirements is the first and most essential element of quality management for our clients. Our team of former FDA consultants and compliance experts are readily available to support each unique situation.Advanced Clinical specializes in:Quality infrastructure engagementsProject-specific quality planningProject support through individuals and/or specialized teamsVALIDATIONAs technology advances, so too does the responsibility of ensuring that facilities, processes, and systems are fully validated. Advanced Clinical’s approach to validation and team of readily deployable consultants, are stringent on the regulations set forth by the FDA to produce products with the highest degree of assurance in meeting all the attributes they are intended to possess.Advanced Clinical supports:Project support through both individuals and specialized teamsFull lifecycle validation and verification engagementsSystem specific oversight and change managementTechnology, risk, and gap assessmentsProject staffing for both short- and long-term initiatives

Provide specialized Quality, Regulatory and Engineering expertise to global biopharmaceutical and medical device clients. Primarily supporting mitigation and resolution of significant quality and compliance issues.