Post-Inspection Response and Support
NSF provides quick and proportionate response services for GxP deficiencies by identifying root causes and determining effective corrective and preventive actions (CAPAs) to help you avoid costly recurring deficiencies.
We support organisations through risk assessments, product quality evaluations and detailed root cause analysis. In addition to helping our clients revise existing policies, we support the design of new policies, procedures and records. We also ensure sustainable improvements by coaching individual behaviour and supporting changes in team culture.
Fix regulatory issues for the long-term and avoid similar issues in the future through our coaching and mentoring services and simplification projects. Our coaching and mentoring services support effective corrections, corrective actions and preventive actions with sound effectiveness checks.
We also respond to all types of regulatory communications, assist in regulatory meetings and act as expert witnesses or subject matter experts.
We offer the following services:
- FDA responses
- EMEA responses
- Regulatory agency meeting preparation
- Action plan development
- Expert witness