Operational Support
Facilities and Equipment
Whether you need an expert assessment of a specific technical issue or a complete review of your new or existing facility, NSF provides a full range of services to ensure your facilities and equipment are qualified and validated, meeting applicable requirements and standards.
Our services include:
- Facility review or design
- Process scale-up
- Computer systems validation
- Facility, equipment and utility validation
- Process validation
- Tech or design transfer
- Troubleshooting
Product
Our experts have comprehensive knowledge of regulatory requirements and agency interactions as well as the technical expertise to solve complex issues. We utilise a systems-based approach to compliance within the major pharmaceutical subsystems, including facilities and utilities, laboratories, material controls, production systems and packaging and labelling.
NSF covers the manufacture of all major dosage forms, including sterile and biotech products. We have experience in the following areas:
- Pharmaceutical packaging
- Sterilisation applications and processes
- Pharmaceutical microbiology
- Supply chain assurance
- Good Distribution Practice (GDP)
- Process and analytical method validation
- Regulatory compliance for computers and automated control systems
- Pharmaceutical water systems
- Providing guidance on product manufacturing and product specifications, including the review and preparation of chemistry, manufacturing and control filings
- Troubleshooting and investigation into product issues
- Suggesting and implementing appropriate and robust corrective actions and preventive actions
- Improving and simplifying product- or process-specific documentation
Our services include:
- Providing guidance on product manufacturing and product specifications, including the review and preparation of chemistry, manufacturing and control filings
- Troubleshooting and investigation into product issues
- Suggesting and implementing appropriate and robust corrective actions and preventive actions
- Improving and simplifying product- or process-specific documentation
Resources
How the QA and QP Talent Market Is Changing in Pharma: Insights from Compliance Unlocked Podcast
PodcastRecruiting and retaining experienced quality and regulatory professionals has become significantly more complex for pharmaceutical and biotech companies.
White Paper: The Global AI Regulation Shift in Pharma Biotech
ArticleHow life science leaders must prepare for AI-enabled regulators across the EU, UK and the United States.
The Foundations of Pharmaceutical Compliance for Beginners
ArticleWhether you’re stepping into the pharmaceutical industry for the first time or pivoting into a compliance or quality assurance role after years of experience, mastering the fundamentals of quality and regulatory compliance is vital to your success—and to the success of your organization.
How NSF Can Help You
