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Quality Standards

We measure against the highest regulatory standards

Data from all our Clinical Trials is measured against stringent regulatory standards, including:

  • International Council for Harmonization Good Clinical Practice (ICH GCP)
  • Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Brazilian Health Surveillance Agency (ANVISA)

Our rigorous project and risk management principles strive for the highest levels of compliance and customer satisfaction.

We are deeply committed to ensuring all our procedures and services are performed in compliance with our internal controls and applicable regulatory standards.

FDA and EMA accept our data for regulatory submissions

The Food and Drug Administration (FDA) and European Medicines Agency (EMA) accept Australian data for regulatory submission. This means data taken from our studies can be used to support international regulatory applications.

Learn about our Clinical Trial experience.

FDA, EMA inspected & ANVISA certified through sponsorship

We have been audited by FDA and EMA, and have undergone Brazilian Health Surveillance Agency (ANVISA) certification.

Stringent and robust Quality Management Systems

Our Standard Operating Procedures are frequently updated to reflect the latest technological and regulatory developments.

Internal Quality Management Systems (QMS) include several safeguards to ensure all client engagements abide by our universal set of regulatory and operational controls.

Nucleus Network QMS safeguards include:

  • Document and data controls
  • Materials controls
  • Change controls
  • Equipment management, and
  • Nonconformance management

Learn more about conducting Clinical Trials with Nucleus Network

 

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