Preparation for Regulatory Inspections

  • Overview
  • Benefits
  • Why Work With NSF?

We have been providing GMP inspection readiness consulting services for decades and our success rate is second to none. Our unrivalled team of former international regulatory agency staff and industry professionals can prepare you for FDA/EMA/MHRA/PICs/WHO and other major regulatory inspections to maximize your potential to succeed the first time.

Our expert services can involve any or all of the following:

  • Initial GAP analysis to identify areas of strength and vulnerability
  • Development of action plan to address vulnerabilities and non-compliances
  • Training of staff in how to interact with the regulatory inspector
  • Formal mock inspection to practice the new skills and challenge staff and systems prior to the inspection
  • Post-inspection support to prepare formal responses and manage ongoing relations with the regulatory agency


Our team of pharmaceutical consultants includes former U.S. FDA and UK MHRA inspectors and experts with decades of experience helping companies develop strategic plans to address warning letters, untitled letters and critical agency findings. Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues.

Why Work With NSF?

This case study provides a real-world example of how working with us can help your company.

Challenge: A manufacturer’s site based in Europe contacted us because it was struggling with multiple GMP deviations, repeat regulatory audit observations and suspected data integrity issues.

Solution: After conducting a full review of the site’s quality management systems, NSF International identified 200 SOPs that could be disposed of, simplified another 50 whose complexity was causing 80 percent of the GMP deviations, trained 20 critical position holders on how to simplify process instructions and SOPs, and reduced the number of test methods and specifications by 60 percent using process mapping.

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