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.
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
News and Events
NSF To Host Pharma Compliance to Performance Conference
September 5, 2024NSF will host its 2nd pharmaceutical conference in London on November 14th, 2024.
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NSF Offers In-Person GMP and Regulatory Compliance Courses at SupplySide West 2024
September 2, 2024NSF is offering a comprehensive GMP and regulatory compliance training program of classroom-based courses for dietary supplement industry professionals at SupplySide West 2024.
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February 2024 Pharma News Update
February 15, 2024The February 2024 update looks at the FDA’s guidance on conducting remote regulatory assessments and more.
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Join NSF at RAPS Convergence 2023
September 12, 2023This year’s gathering of regulatory affairs professionals will take place in Montréal, QC Canada on October 3–5, 2023.
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How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
