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 $300,000,000 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 100,000 – 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

Clear Solutions Consulting, LLC

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