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