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 organizations 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 behavior 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
Ready to Begin the Process?
Contact us with questions or to receive a quote.
News and Events
NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training
May 19, 2020
To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.
NSF International’s Health Sciences Team Joins Fight to Save Lives With More Ventilators
April 23, 2020
NSF International’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.
GMP and MAHs, ICH Q13, and More: October Pharmaceutical News Update
October 18, 2021
NSF Celebrates DSHEA Anniversary with Open Access to Dietary Supplement cGMP eLearning
October 18, 2021