Pharmaceutical Quality System Remediation Projects

Develop an action plan for responding to statements of non-compliance, including warning letters and FDA Form 483s. Incorporate our practical remediation solutions into your overall quality system for long-term, sustainable compliance.
A science professor is giving a lecture to a university class - Pharmaceutical Quality System Remediation Projects | NSF

In an uncertain world, NSF's remediation expertise helps companies around the globe achieve compliance with optimized, pragmatic and risk-based solutions.

Our team of pharmaceutical consultants includes former FDA and MHRA inspectors, as well as industry experts. We help companies develop strategic plans to address enforcement actions from the FDA, MHRA, Health Canada and other global authorities.

Respond to adverse regulatory inspection findings, build a compliant quality system or implement a remediation plan to prevent problems in the future. We work with you to build a quality system that is sustainable for your business.

Receive a risk-based gap assessment, corrective action plans and ongoing implementation support. We also provide ongoing coaching and mentoring for team members at all levels to ensure your culture changes in a sustainable way.

We use a systems-based approach to compliance and cover all major pharmaceutical subsystems, including:

  • Quality systems
  • Laboratories
  • Material controls
  • Facilities and utilities
  • Production
  • Packaging and labeling

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.