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• Quality Compliance
• Regulatory Compliance
• cGMP Audits
• Quality Program Development and Enhancement
• Validation Program Management
• Facilities Qualifications
• Start-up and Commissioning Activities -
Provide experienced industry leaders to meet customer’s compliance needs.
Specialize in establishing, executing, and implementing customer compliance programs.
Evaluate compliance programs and perform risk assessment and management. -
Validation Programs
Life Cycle Approach
IQ/OQ/PQ Programs
New and Existing Facility Validation
Equipment Qualification
Process Validation
Sterile and Non-Sterile Facilities -
Change Control
Cold Chain Management
Container Closure Integrity
Leachables and Extractables
Environmental Monitoring
Non-Conformance
Customer Complaints -
QA Program Development
Change Control
Cold Chain Management
Container Closure Integrity Program
Leachables and Extractables
Environmental Monitoring
Program/Product
Management
• Client’s Representation
• Consulting and Strategic Planning
• Project Estimating and Budgeting
• Project Scheduling
• Design Management
• Construction Management
• Design/Build Project Management
• Procurement
