TrueNorth Quality Partners provides GxP & AI governance auditing, consulting and training (ACT) for regulated Research, Pharmaceutical, Biotech, and Public Health Organisations navigating local, national, regional and global guidelines and requirements.
Delivered on-site and remotely in the United States, Canada, India, Spain, France, Malta, Italy, Germany, Romania, Sweden, Norway, Ireland and the Netherlands — and open to auditing, consulting and training engagements worldwide.
Most consultancies do one of these well. TrueNorth was built around the fact that regulated organisations now need all three at once.
GMP, GCP, GDP, GLP and GVP audits, gap analysis and CAPA support aligned to regulatory authorities expectations.
Readiness assessments, management-system build-out and lead-auditor support for organisations deploying AI in regulated environments.
Pharmacovigilance quality assurance and data protection compliance for digital health platforms, data-driven trials and medical devices.
Deep GxP audit experience and formal AI-governance credentials rarely sit in the same practice. That intersection is precisely where updated guidelines, robust frameworks and methodological training are now colliding — and where most quality teams have the least support – the trinomial Auditing, Consulting and Training (ACT).
Direct auditing experience with suppliers, third-party manufacturers and other contract organisations across quality systems and inspection readiness.
GxP and AI-governance auditing, consulting and training for pharmaceutical and biotech quality teams — all three, one practice.
A practical reading of the standard for QA departments that are neither IT nor data-science teams.
Why clinical and hospital quality auditing remains underserved locally — and what that means for providers.
