NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, residential and on-site pharmaceutical training and clinical testing on a global basis.
Recent public health concerns and challenges have underscored regulators' proactive pursuit of compliance in the pharmaceutical industry. The market's need for outsourced, independent, third-party pharmaceutical and biotech support services has been recognized by industry experts. NSF offers solutions tailored to your industry requirements and company-specific objectives. Our staff of former EU and FDA officials, in addition to our industry experts, enables us to combine global regulatory knowledge with industry best practices to help our clients achieve what they need to, all whilst remaining updated during an increasingly turbulent time of change.
Our 'Not for Profit' status means we act in your long-term best interest based on good science, expert experience and common sense. We care about you, our clients, which is why over 87% come back for more.
Our Specific Services: Providing you with Solutions across the Product Life Cycle
- Customized education programs that will change behaviors, improve performance and 'future proof' your organization. You are only as good as your people!
- Qualified Person Education. More people have become 'QPs' in Europe through our QP training program than any other training provider
- Remediation consultancy. Helping you successfully manage Warning Letters, Consent Decrees, Import Alert Notifications, WHO 'de listing' and removal of manufacturing and marketing licenses in the EU. With us you will become better prepared and emerge as a stronger company
- Quality System simplification, implementation, compliance assessment and benchmarking against best industry practice. We want you to have a Quality System that will provide you with commercial advantage. One that is simple and effective
- Regulatory Inspection Readiness and 'Mock Inspections'. We will help you to succeed in your next FDA, EU or WHO Inspection
- Data integrity assessments. Let us help you find and close the gap before it's too late
- Helping you to Error Proof your processes and systems and drive Continuous Improvement
- Leadership Development and Coaching
- Auditing of Third Parties and Suppliers. Let us help you to sleep easy at night!
- Due Diligence Audits. We will help you spend your money wisely
- Auditor Certification. We will independently 'certify' your GMP auditors so you can be confident with their findings
- GMP remediation. Programs that provide a sustainable, proportionate and comprehensive roadmap to survive and then thrive in the field of bio and biosimilar manufacturing
- Corporate due diligence, risk assessment and specialist consultancy when acquiring or merging with bio production facilities outside your organization
We help you enhance and embed the right culture throughout your organization. The right people. The right solution. The first time.