Pharma and Biotech

Leveraging our extensive industry expertise and a solid reputation in third-party auditing, we specialize in delivering consulting, training, and auditing services for the world's largest and most dynamic companies in the pharma biotech industry.

We support you throughout the product lifecycle with the development, manufacture and delivery of safe and effective products. NSF helps you bring your products to market cost-effectively and time efficiently.

Our global consulting experts, including former regulators and industry experts, help pharmaceutical and biotech companies establish or remediate quality systems, mitigate risks and achieve sustainable compliance.

Explore Our Solution Areas

Pharma and Biotech Industry Audit Services

NSF experts perform audits and mock inspections across the product lifecycle. Read the article to find out more.

Preparing for GxP Inspections

Identify key risks and follow expert mitigation strategies prior to your GMP inspection. We'll help you prioritize and address concerns, creating perpetual inspection readiness.

Post-Inspection Response and Support

Obtain timely pragmatic solutions for your GxP findings and develop effective next steps to meet regulatory requirements and expectations.

Regulatory Strategy and Submissions

Receive customized regulatory pathways to bring innovative pharmaceuticals, biologics, gene and cell therapies and combination products to market efficiently.

Pharma and Biotech Quality System Support

A strong quality system (QS) provides a critical foundation for all pharmaceutical and biotech companies.

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.

Health Management Systems Certifications

Whether you produce pharmaceutical drug products or biologics, mitigate risk and protect your health industry business with the help of NSF-ISR.

Pharmaceutical Training

Bring about change that drives improvements. NSF’s pharmaceutical training and education programs focus on changing behaviors at both an individual and organization-wide level.

Coaching and Mentoring Services for New Pharma People

Assess the leadership capabilities within your staff and support direct reports in their career development with NSF's coaching and mentoring services.

Operational Support

Receive an expert assessment of your facilities, equipment or products.

Data Integrity Support for Pharma and Biotech

We offer training, risk evaluations, audits and collaborative systems assessments to assist with your ongoing data integrity needs. Our experts also provide guidance for addressing regulatory findings and implementing data integrity governance systems.

Morphology-Directed Raman Spectroscopy (MDRS) to Support In-Vitro-Bioequivalence (IVBE) Studies

Cutting-edge technology providing rapid and automatic chemical and morphological characterization, drug consistency evaluation and formulation analysis services to accelerate generic drug development.

The Right Training for Your Team

Our interactive training courses are based on real-world scenarios and designed to help you meet international requirements, no matter where you are located.

Learn more about our training

Resources

The Powerful Role of Outsourcing in Regulatory Compliance Excellence

In the highly regulated environments of the medical device and pharmaceutical industries, regulatory documentation is far more than a compliance checkbox. It’s a strategic asset that supports product lifecycle management, risk mitigation, and global market access.

What Is NSF’s Quality Management Maturity (QMM) Assessment Model? Find Out More

It is well recognized that the Quality Management System (QMS) - whether documentation, deviation, event management or CAPA – is the focus of Regulatory Inspections and indeed the cause of many findings. Given that the requirements have been broadly the same for so long, why is this still an area of non-compliance?

Ireland: How The Irish Life Sciences Sector is Leading the World

Ireland is a life sciences powerhouse. In this article, NSF experts look at the issues driving the success of the sector in Ireland and the challenges that it is currently facing.

News and Events

NSF To Host Pharma Compliance to Performance Conference

September 5, 2024

NSF will host its 2nd pharmaceutical conference in London on November 14th, 2024.

NSF Offers In-Person GMP and Regulatory Compliance Courses at SupplySide West 2024

September 2, 2024

NSF is offering a comprehensive GMP and regulatory compliance training program of classroom-based courses for dietary supplement industry professionals at SupplySide West 2024.

February 2024 Pharma News Update

February 15, 2024

The February 2024 update looks at the FDA’s guidance on conducting remote regulatory assessments and more.

Join NSF at RAPS Convergence 2023

September 12, 2023

This year’s gathering of regulatory affairs professionals will take place in Montréal, QC Canada on October 3–5, 2023.

How NSF Can Help You

Get in touch to find out how we can help you and your business thrive.