Pharma Quality Systems and Compliance

Strong and robust quality systems are required for companies to consistently and reliably produce safe, high-quality products and services. Not addressing concerns highlighted in FDA 483s and FDA warning letters can potentially halt production or, worse, result in a recall, import bans, detention or product seizure, which can damage your organization’s pipeline, financial well-being and reputation. With relentless, often subtle, changes to guidelines released by regulatory authorities around the world, it can be challenging to stay up to date. With substantial experience in creating, implementing, reviewing and remediating quality systems for a variety of organizations, NSF Health Sciences Pharma Biotech is the premier source for assistance with any question or issue related to quality systems.

We utilize a systems-based approach to compliance covering the major pharmaceutical subsystems including:

  • Quality system
  • Laboratory controls
  • Material controls
  • Facilities and equipment
  • Production system
  • Packaging and labeling

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