WELCOME
Architects of Quality is a strategic and tactical consulting firm specializing in quality & GxP compliance services.
We partner with leaders across the pharmaceutical, medical device, and combination product sectors to accelerate strategic growth and position quality as a competitive advantage.
Areas of Expertise
Audits & Inspection Readiness
Own your inspection success. ​Prepare confidently for Health Authority inspections (US FDA, EU EMA) and Notified Body audits (ISO, MDSAP) with expert audits and assessments that provide actionable insights to unlock future inspection success. Use these insights to build an inspection readiness playbook and create your next inspection success story.
QMS Development & Optimization
Your QMS. Your Quality signature. It defines and controls the processes intended to ensure your deliverables consistently meet established expectations. Whether developing a QMS from scratch or fine-tuning for improved performance, we can help.
Training & Development
Internal expertise. Sustained success. Combine foundational QMS theory with tailored process expertise to build internal capabilities and establish Centers of Excellence. Our professional capabilities building platforms can help identify your future business leaders today.
Remediation & Risk Management
Find your fix to restore confidence. How you respond to identified deficiencies can set you apart from the competition. A robust remediation pathway demonstrates a commitment to operational integrity and continuous improvement. Let's design a remediation strategy that meets the moment - both for your organization and the patients that count on you.
KPIs & Performance Management
Actionable insights. Impactful solutions. Complete your QMS strategy by integrating concise and actionable datasets that help you focus on what matters most. Let's unlock that proactive performance management potential together.
Regulatory Intelligence
Stay informed. Stay compliant. While regulations are considered the bare minimum for compliance, many business elect to adopt industry guidance and international standards as a way to earn a competitive edge. Our PULSE platform provides expert insights to help you stay informed.