• Quality by Design
• Development of Quality Systems
• Evaluation of Site Compliance to System’s Based Inspection Guidance
• Aid with implementation of Quality Problem Solving Tools
• Assist with investigation resolution, reduction of investigations, root cause analysis
• Change Control Program Review and Assessment
• Development of policies, procedures, quality manuals, and so forth
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  Development of product history files
  

Biologics

• Preparation for pre-approval approval submissions
• Troubleshoot contamination problems
• Facility and manufacturing line assessments
• Review of validation requirements for cGMP operations
• Development of environmental monitoring programs
• Development of contamination control programs
• Qualification of Laboratory Equipment and Methods
• Review/assess qualification of aseptic processes

Manufacturing Support

• Process Optimization
• Documentation Systems
• SOP and validation assessments and audits
• Preparation and review of documentation, e.g., protocols, procedures, work instructions
• Reduction of Investigations
• Corrective and Preventative Actions (CAPA Programs)
• Risk Assessment
• Project Management
• Comparability Protocols to Implement Changes in a more timely fashion
• Training
• Change Control Support
• Failure Analysis and Remediation