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Quality Management Support

Quality management system development / improvement / monitoring according to GCP, GVP, GDP and ISO 9001

  • Setup and implementation of quality management systems adapted to your business needs with standardized processes reflecting the particularities of your organization, in compliance with legal/regulatory requirements;
  • Review of existing quality management systems for compliance/effectiveness/efficiency and suggestion of alternative solutions;
  • Reengineering of existing quality management systems to improve their compliance, effectiveness and efficiency, and to reduce the effort and resources required;
  • Development and review of quality management system documents;
  • Assumption of quality management responsibilities and duties.

 

Quality management consulting

  • Identification of improvement areas and development of appropriate risk-based action plans
  • Consulting on individual quality-related issues
  • Consulting on and/or support for GCP, GVP and GDP audits/regulatory inspections (preparation and follow-up)