Pharma and Biotech Quality System Support

A strong quality system (QS) provides a critical foundation for all pharmaceutical and biotech companies.
Two doctors working in the office of a hospital - Pharma and Biotech Quality System Support | NSF

With experts who specialize in every area of a QS, NSF helps you develop best practices, coach, mentor and train staff in investigations, simplify documentation and evaluate the costs of poor quality.

Quality Systems

Implementation of quality systems (QSs) can be difficult. We believe your QS content should be simple and easy to follow, from your quality policy and quality manual to your procedures and work instructions.

NSF's evaluation, diagnosis, guidance and effectiveness (EDGE) tool assesses your existing QS and offers recommendations for improvement. NSF's team of experts has detailed knowledge of every QS area. We assign the right expert to review and update your policies and procedures, ensuring they meet global regulatory expectations and requirements.

Process Optimization

We review and improve processes, offer staff training and qualify people to conduct investigations. We can also support your quality risk management and investigation processes, including root cause analysis. Let us help you develop appropriate corrective actions and preventive actions with sound effectiveness checks.


NSF simplifies standard operating procedures (SOPs) and batch manufacturing records (BMRs) to ensure they are accurate and easy to follow. We work collaboratively to identify the key steps in a procedure or manufacturing process, then design documents using flow charts and decision trees. Our simplification process results in more manageable documents and fewer staff errors.

Cost of Poor Quality Analyses

Highlight manufacturing or testing processes that need improvement with a cost of poor quality analysis. Use cost of poor quality data to encourage senior managers to invest in necessary improvements by shifting the costs associated with rejects, rework, deviations and investigations to positive investments in your company.

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.