Quality. Integrity. Trusted GxP Excellence for Medicines Policy and Public Health
15 years of expertise in GxP consulting, regulatory auditing, and compliance assurance for pharmaceutical and public health organizations. We partner with industry leaders to ensure operational excellence, regulatory readiness, and data integrity.
Comprehensive GxP consulting and regulatory support tailored to your organization's needs
Complete assessment of quality systems (GMP, GCP, GDP, GVP, GLP) with gap analysis, regulatory alignment with FDA, EMA, and PIC/S standards. We develop CAPA plans and implement corrective actions for full compliance.
Realistic simulations of regulatory inspections to prepare your team and identify non-conformities. Includes debriefing, remediation recommendations, and staff training for maximum readiness.
Proactive identification and management of regulatory risks with mitigation strategies. Expert support responding to regulatory findings (Warning Letters, 483s, Inspection Reports).
Specialist support in data integrity, pharmacovigilance (GVP), and good distribution practice with focus on privacy, security, and GDPR compliance in public health and drug safety.
Strategic guidance on regulatory submissions, CMO oversight, and complex compliance projects. We coordinate multi-functional initiatives ensuring regulatory alignment and operational success.
Industry-leading expertise in GxP and regulatory compliance
TrueNorth Quality Partners brings deep expertise in Quality Assurance, regulatory auditing, and compliance consulting within the pharmaceutical and public health sectors. Our team has successfully supported multinational organizations in achieving regulatory excellence and operational integrity.
We specialize in GxP (Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good Pharmacovigilance Practice) and provide strategic support for regulatory readiness, compliance transformation, and risk mitigation.
ISO 9001, 14001, 19001, 22000
Medical Devices Compliance
PIC/S GxP Standards
WHO Guidelines
Portugal & Netherlands
Tell us about your compliance needs. We'll respond within 24 hours.