New Synergy Consulting is an American based consulting firm that operates in the following FDA regulated industries: Medical Device, Pharmaceuticals, Bio-Medical, and Tobacco (PMTA). We specialize in validation, remediation, and project development. Unlike other consulting firms, New Synergy is engineer owned and operated. We have assisted in developing large scale 483 remediation projects including: readiness inspections, gap analysis, project timelines, defining roles, and staffing resources. In addition to project development, we are experts in process validation (IQ, OQ, PQ, TMV, and software validation), design controls, EUMDR, and risk management.
