NSF designs and implements robust solutions related to the complex development, approval, marketing and manufacturing of FDA-regulated products throughout the total product lifecycle.
Three key indicators are at the heart of our most successful, positive and sustainable remediation projects:
Your company's culture, organization and support systems directly impact how teams execute remediation activities. Remediation projects succeed when a company aligns its organization with a common vision to meet regulatory requirements and support business strategy.
NSF offers planning and strategic services that help companies align business goals with regulatory requirements. From corrective action planning to quality system remediation, NSF supports your team's remediation efforts.
Clear and consistent communication ensures that members of your organization have a common understanding of why sustainable organizational improvements are required. It includes detailed plans and strategies for remediation project activities, as well as expectations for directly affected personnel and support staff. Communications must be planned, measured, consistent and managed to ensure organization-wide support for your efforts.
In addition to planning and strategy support, NSF provides the following communication services:
- Medical devices FDA Form 483 correspondence
- Warning letter responses
- Regulatory agency major nonconformity responses
- Field safety notices (FSNs)
- Field safety corrective actions (FSCAs)
- Recall letters and correspondence
- Patient and user communications
Establishing a quality system that meets your regulatory and business needs is challenging enough. In most instances, it requires the input of third-party experts. Strengthening relationships between team members and your overall organization spurs organizational change. As team members collaborate toward a common goal, they share openly, discuss solutions and build consensus.
To support your company as you collaboratively identify and address gaps, NSF conducts baseline assessments, due diligence assessments, third-party internal audits, FDA mock regulatory readiness inspections and QSIT audits.
Your success is our success. When you use the right expertise to develop the right solutions, your organization stays on the road to sustainable quality.
Ready to Begin the Process?
Contact us with questions or to receive a quote.
NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020
NSF’s Remediation Resources
Insights and Expertise
Case Study: A Tale of Two Pharmaceutical Remediation Projects
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