Analytical Research & Development

• Program design from concept to protocol development
• Laboratory design including instrument selection, IQ, OQ, PQ
• Validation planning & design including PQ test cases
  

Quality Assurance

• Design and development of Quality Management Systems
• Quality Metrics including CAPA
• Validation support including development and planning
• Computer compliance
• DEA sample handling and systems
• Vendor Audits
• On-site GMP audits
• Laboratory equipment validation
• Regulatory affairs support
• On-site GMP/GLP training

Information Technology

• Computer Compliance
  • Policy
  • Validation Services
  • Gap Analysis
  • System Design
• IT SOP Review
• Security Audit
• System Mapping
• IT Policies
  • Acceptable Use
  • Anti Virus
  • Acquisition Assessment
  • Email and Email Retention
  • VPN
  • System Lifecycle
• IT Vendor Audits
• IT Vendor Selection
• IT Functional Testing
• IT Risk Assessment
• IT Inventory
• Project Management
• Disaster Recovery
• Nautilus LIMS
  • Project planning and management
  • Extensions and work flow configuration