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.

In an uncertain world, NSF's remediation expertise helps companies around the globe achieve compliance with optimised, pragmatic and risk-based solutions.

Our team of pharmaceutical consultants includes former FDA and MHRA inspectors, as well as industry experts. We help companies develop strategic plans to address enforcement actions from the FDA, MHRA, Health Canada and other global authorities.

Respond to adverse regulatory inspection findings, build a compliant quality system or implement a remediation plan to prevent problems in the future. We work with you to build a quality system that is sustainable for your business.

Receive a risk-based gap assessment, corrective action plans and ongoing implementation support. We also provide ongoing coaching and mentoring for team members at all levels to ensure your culture changes in a sustainable way.

We use a systems-based approach to compliance and cover all major pharmaceutical subsystems, including:

  • Quality systems
  • Laboratories
  • Material controls
  • Facilities and utilities
  • Production
  • Packaging and labelling

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