Overview

• New Synergy Consulting operates specifically in FDA-regulated industries including Medical Device, Pharmaceuticals, Bio-Medical, and Tobacco (PMTA)
• The company is engineer-owned and operated with 5 employees based in Salt Lake City, Utah, United States
• Specializes in validation, remediation, and project development for FDA-regulated sectors
• Has developed large-scale 483 remediation projects involving readiness inspections, gap analysis, and staffing resources
• Provides expertise in process validation (IQ, OQ, PQ, TMV, software validation), design controls, EUMDR, and risk management

Specializations

• Medical Devices
• Pharmaceuticals
• Biotechnology

Services & Approach

• Process validation including IQ, OQ, PQ, TMV, and software validation
• 483 remediation projects with readiness inspections and gap analysis
• Project development including timelines, role definition, and staffing resources
• Design controls, EUMDR, and risk management implementation