BQG has extensive experience in Operations & Quality Assurance covering Manufacturing core processes and Routine Quality systems.

We assist our customers in their various operational quality assurance tasks. Our consultants can provide tailor-made services to efficiently support quality operations:

  • Implementing the latest industry standards and trends: ICHQ8/Q9/Q10, FDA Guidance for Industry,
  • Change control, deviations, CAPA, complaints and OOS analysis and remediation,
  • Risks analysis,
  • Root cause analysis,
  • Periodic review,
  • GMP documentation streamlining (SOP, Batch record,...)
  • Support to regulatory events such as recalls or warning letter.

Case Study

Contact us to discuss your Operations and/or Quality Assurance project.