Post-Inspection Response and Support

Obtain timely pragmatic solutions for your GxP findings and develop effective next steps to meet regulatory requirements and expectations.
A male hospital administrator gestures during a staff meeting discussion - Post-Inspection Response and Support | NSF

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’s Health Sciences Team Joins Fight to Save Lives With More Ventilators

April 23, 2020

NSF’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.

March 2023 Pharma News Update

March 1, 2023

The U.S. NIST has developed a framework to better manage risks to individuals, organizations and society associated with artificial intelligence (AI).

March 2023 Medical Device and IVD News Update

March 1, 2023

Welcome to our March Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.