Tyanna Hadley

Senior Consultant, GxPAssure

Tyanna Hadley is a strategic regulatory compliance professional with extensive experience across FDA inspection, pharmacovigilance, bioresearch monitoring, REMS, and pharmaceutical quality oversight. With a strong scientific and regulatory background, she brings valuable insight from her work as a US FDA Investigator, where she conducted more than 50 inspections across pharmaceutical, biologic, medical device, veterinary medicine, CRO, IRB, sponsor, pre-clinical, clinical, and pharmacovigilance environments.

Her experience spans regulatory agency, pharmaceutical industry, nonprofit leadership, and consulting roles, supporting organisations with inspection readiness, compliance remediation, risk management, and sustainable quality systems. Tyanna combines regulatory expertise, scientific knowledge, and strong leadership capability to help teams navigate complex compliance challenges while maintaining a clear focus on patient safety, healthcare quality, and operational excellence.

Key Skills and Areas of Expertise

• FDA and global regulatory compliance, including GxP, ICH, and bioresearch monitoring requirements
• FDA inspection conduct, inspection readiness, audit preparation, and regulatory response support
• Pharmacovigilance, drug safety oversight, REMS compliance, and global regulatory reporting
• Corrective and Preventative Action development, root cause analysis, risk mitigation, and compliance remediation
• Cross-functional leadership, stakeholder engagement, scientific writing, and regulatory communication
• Quality system development, programme management, nonprofit governance, coaching, and professional development