Our Expertise in Quality Factors:

  • Establishment & Assessment of the Quality Management System (QMS)
  • Assessment of all Quality Systems (Manufacturing, Packaging & Labelling controls, QMS System, Laboratories control system, Material and Inventory Control system and Facility & Equipment control system
  • Perform all types of Quality Audits and support in QA audits for all regulatory markets.
  • Perform specific audit only for Data Integrity
  • Performing stage 1 Audits and providing pro-active inputs on system implementation and improvement
  • Reviews and Gap Analysis for:
      • Regulatory Compliance, Suitability & Adequacy
      • Sterility Assurance
      • Trend Analysis
      • Statistical Process Performance/Capability Analysis
  • Annual Product Review
  • Support in investigations:
      • Failures Investigation
      • Guidance, Reporting
      • Review and CAPA
      • Position Papers