• Philosophy
    • Represent the best interest of our clients
    • Involve QA Early
    • Work as if we are our client’s employees
  • Approach
    • Establish consensus of requirements early, repeat them
    • Communicate, small issues will grow
    • Define roles and responsibilities early, repeat them
    • Realize that ownership during project lifecycle will change, global engineering to plant engineering to operations. Understand the transition and respond to their needs.
    • Minimize reviewers and approvers
    • Who can authorize changes?
  • Services
    • ASTM E2500 Implementation
    • Master Planning
    • Project Management
    • SOP Preparation
    • Project Staff Augmentation
    • Boundary Drawing Preparation
    • Change Control
    • Protocol Preparation, Execution and Summary Reporting
      • Utilities Testing (direct and indirect impact)
      • Tablet and Encapsulation Machine Qualification
      • Process and Filling Systems Qualification
      • Packaging Equipment Qualification
      • Sterilization Equipment Qualification
      • Sterilization Equipment Qualification & Cycle Validation
      • Lyophilization Equipment Verification & validation
      • Computer System Validation
        • Building Automation Systems
        • Process Automation Systems
        • Vendor Controls