Vision: Solving Quality and/or Compliance business problems for organizations in need within the Pharmaceutical and Medical Device Industries. Mission: Hiring qualified professionals to in need to perform those roles. Service(s): (1) Manufacturing operations improvement; (2) Productivity improvement; (3) Quality assurance and Quality control; and (4) Quality Audits Services is also not limited to: • Batch Record Review • Non-conformance Investigation • Quality Compliance Investigation • Environmental Monitoring • Root Cause Analysis • Implementation • Internal and External Audits • SOP creation and updates • cGMP, Compliance training • Label Q.A. & QC Review • Deviation investigations • Product & Medical Device Complaints Investigation • Corrective & Preventive Actions • Annual Product Review (APR) • Continuous/Process Improvements • MedDevice Complaints: Intake, investigation, and Closures • Metrics • Medical Device Investigation • Medical Device Reporting • PSURs • Quality & Compliance Inspection • Assistance with FDA issued 483s • Assistance with Drug recalls • Assistance with MedDevice Recalls