Our Approach
Our Validation Engineers can plan, execute, deliver and manage all of your Engineering needs in Biotech and MedTech from strategy to hands-on projects.
Validation in BIOTECH & MEDTECH
• Validation Master Plan (VMP) Generation
• Computer System Validation (CSV) & Data Integrity
• Process validation of drug substance (Upstream or Downstream)
• Process validation ofdrug prodcut (Fill and finish, lyophilisation)
• Commissioning & Qualification Validation (CQV)
• Validation Risk Assessment
• Cleaning Validation (Cross Contamination Risk Assessment)
• Equipment Qualification (Processing & Packing)
• Process Qualification & Validation
• Utilities Validation (HVAC, Purified Water, Compressed Air)
• New Facility Qualification
