Pharma Compliance and Quality Systems

  • Overview
  • Benefits
  • Why Partner with NSF?
  • Process

NSF International provides third-party system-based gap analyses as well as targeted assessments of GxP systems. Employing proven methodologies and extensive staff expertise, we assist companies with the design and implementation of corrective action plans. Our wealth of experience has also helped many companies navigate communications with the FDA and successfully overcome FDA enforcement actions from FDA 483 inspectional findings to warning letters to consent decrees.

We specialize in helping companies build and own sustainable, efficient and practical quality systems that meet their business needs and fulfill regulatory requirements, whether as part of an urgent remediation effort or as a preventive measure.

Benefits

NSF helps your company build sustainable, efficient and practical quality systems that meet your business needs and fulfill regulatory requirements:

  • Our staff consists of industry experts as well as former FDA regulators, assuring alignment with FDA expectations and capitalizing on industry technical know-how.
  • We have developed proven methodologies and a record of success with complex quality and regulatory issues.
  • Our expert advice and guidance assures your company becomes self-sufficient with ownership of the enhanced system.
  • Our detailed knowledge of industry best practices assures practical, doable systems.
  • Our total product lifecycle approach embodies the concepts of a quality system by establishing links between phases and capturing feedback throughout the lifecycle.

Why Partner with NSF?

We are committed to providing only the highest quality services based on sound science, risk assessment and common-sense pragmatic solutions to help our clients achieve their goals. Initial consultations are provided as a professional courtesy.

Process

Working with NSF to establish pharma compliance and quality systems encompasses one or more of these processes:

  • Third Party GxP System-based gap analyses
  • Targeted assessments
  • Mock FDA audits
  • Corrective action development and implementation
  • Enforcement action remediation and compliance support
    • FDA-483 and warning letter responses
    • Injunction (consent decree)
    • AIP resolution
    • Corporate integrity agreement

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