Consulting Services

Our consulting services that we offer with the cooperation of our business partners for the sector

  • Audit Preparations (Titck – Turkish Medicines and Medical Devices Agency)
  • Audit Preparations (EU GMP)
  • Audit Preparations (Contract manufacturer)
  • Supplier Audits
  • Pharmaceutical Quality Management System Establishment
  • Risk Based Production of Pharmaceutical Products
  • Quality control
  • Outsourcing
  • Customer Complaints and Withdrawals
  • Out of Limit Management
  • Internal Audits
  • ICH Q9 Quality Risk Management
  • Data Integrity
  • Qualification and Validation
  • Validation of Computerized Systems
  • Process Validation
  • Packaging and Packaging Validation
  • Cleaning Validation by PDE Approach
  • Water Systems
  • Air Systems and HVAC Qualification
  • Technology transfer
  • Equipment (Clean-Dirty) Waiting Times
  • Risk Analyzes for Nitrosamine
  • ICH Q3 D Risk Analysis for Elemental Impurities
  • Quality Agreements
  • Hygiene
  • Risk-Based Evaluation of Deviations
  • ICH Q1A Stability
  • ICH Q2 Analytical Method Validation and Method Transfers