Remediation / Quality Systems Compliance

NSF International has substantial experience in creating, implementing, reviewing and remediating pharmaceutical quality systems (QS) for a variety of organisations.

Strong and robust quality systems are required for companies to consistently and reliably produce safe, high-quality products and services.

Regulatory inspections from authorities may require pharmaceutical biotech companies to respond to specific enforcement actions. NSF International helps with regulatory compliance through an experienced team, which includes former US Food and Drink Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) inspectors with decades of experience.

Helping companies develop strategic plans to address enforcement actions for regulations such as the FDA, MHRA, and Health Canada, NSF provides you advice on how to respond to adverse regulatory inspection findings and build a compliant pharmaceutical quality system (QS) to avoid future problems.

We utilise a systems-based approach to compliance, covering major pharmaceutical subsystems including:

• QS
• Laboratory and material controls
• Facilities and equipment
• Production system
• Packaging and labelling

NSF’s process involves a risk-based gap assessment, development of corrective action plans, and ongoing support with implementation. We focus on education and behavior at all levels to ensure a sustainable quality culture change. We work with you to build a sustainable QS to help enhance your business.