Our Services

• 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