Clear Solutions Consulting, Llc

Engineering, Quality & Regulatory Consulting Partners have over 55 years combined experience in Engineering and Construction Management, Quality Assurance and Regulatory Affairs in FDA and EMA regulated environments, Validation in bulk active and sterile drug manufacturing and world class maintenance practices. Engineering Management • Project execution program development • Facility Master Planning • Facility and Process design Bulk active Potent compound handling Clean rooms to Class 100 • Cost proposal preparation • Construction Management Past project management for facility Regulatory • Quality Assurance cGMP compliance auditing, both internal and for external suppliers Quality systems development, meeting all FDA cGMP requirements for drug and devices cGMP training for management and line personnel SOP development FDA inspection preparation Mock Pre-Approval Inspections Quality System KPI assistance ISO 9001 and 13485 preparations • Regulatory Affairs Document preparation for API and Excipient regulatory submissions • Validation Master plan development to provide value added approach Protocol development and execution Process and equipment validation from bulk to sterile final dosage Sterilization cycle development for autoclaves (including product terminal sterilization) Cleaning program to eliminate cross contamination HVAC and Clean room certification, Class – Class 100 21CFR Part 11 – real world, least burdensome approach Establish annual requalification program Calibration/metrology program Management of Change Maintenance • Program development • Productivity improvement Activity based management Benchmarking to “best of best” industry metrics • Reliability assessment • Preventive and predictive maintenance program development • CMMS implementation