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