Accelerating Drug Development

Quality Assurance: Building Quality Systems

CQS consultants have extensive knowledge and experience in operations, clinical, non-clinical, quality, and IT, and provide a range of support — from professional advice and expertise-sharing to interim management, hands-on implementation, and training. We work with you to develop the processes and procedures customized for your needs, to ensure compliance, effectiveness, and efficiency. Our services include:

  • Complaints Management
  • Development, implementation, and management of quality management systems
  • Development and/or review of clinical operation systems
  • Vendor Oversight & Management (Selection / Qualification Services)
  • Vendor Selection / Qualification Services
  • Risk Management
  • Quality Manual / Policy Generation and Review
  • Internal / External Auditing & Mock Audits
  • Creation of Training Programs / Personnel Training
  • Batch Record Review / Disposition
  • Quality Management Review Process / Gap Assessments
  • Event Investigations, CAPAs, Deviations, RCAs & OOSs
  • Regulatory Submission Review
  • Quality Metric Programs
  • Supply Chain Oversight
  • Change Control
  • SOP Writing / Review