• Qualified Person (QP) Services
• Interim and Crisis Management within Q (QP, QA, QC) and Operations
• Quality Assurance (QA) Activities:
  • Deviation Management
  • Out of Specifications (OOS) Handling
  • Annual Product Reviews
  • Complaint Handling
  • Change Management
• Quality Control (QC) Management
• Quality Risk Management (QRM)
• Quality Management Systems (QMS) Improvements
• Auditing
• Preparation for Regulatory Inspections/Notified Bodies (NBs)
• GMP and GDP Compliance for Facility Design and Operations
• Scientific Problem Solving
• Project Management, including Global SAP Implementation
• Medical Devices and Combination Products (MDCP)