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
Resources
FDA Inspection Readiness: What Inspectors Look for Beyond SOPs, FDA 483 Responses and Quality Culture
PodcastIs your quality system ready for regulatory scrutiny? Former FDA investigator Dr. Julia Marré shares practical guidance on quality culture, site preparation and effective Form FDA 483 responses.
FDA Inspections and Form 483 Responses: What Companies Need to Know
ArticleAn FDA Form 483 response can influence how inspection findings are classified and what happens next. Drawing on NSF webinar insights from former FDA experts Tamika Cathey and Dr. Julia Marre, this article explains what companies should do within the critical 15-business-day response window and where responses often fall short.
How the QA and QP Talent Market Is Changing in Pharma: Insights from Compliance Unlocked Podcast
PodcastRecruiting and retaining experienced quality and regulatory professionals has become significantly more complex for pharmaceutical and biotech companies.
How NSF Can Help You
