Operational Support

We review building plans for new or existing facilities and provide strategic and expert advice on the manufacture of all dosage forms, including sterile, biotech and advanced products.

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

Our experts have comprehensive knowledge of regulatory requirements and agency interactions as well as the technical expertise to solve complex issues. We utilize a systems-based approach to compliance within the major pharmaceutical subsystems, including facilities and utilities, laboratories, material controls, production systems and packaging and labeling.

NSF covers the manufacture of all major dosage forms, including sterile and biotech products. We have experience in the following areas:

• Pharmaceutical packaging
• Sterilization 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