David
Blackett
CEO and Founder
GxP Quality
ABOUT ME
I am a GxP quality and compliance professional with over 25 years of experience supporting life science organizations across clinical development and regulated environments.
All work is performed directly by me as a senior GxP auditor. There are no junior staff, no handoffs, and no dilution of accountability.
I have led the design, implementation, oversight, and auditing of quality management systems across GCP, GLP, GMP, and GVP, supporting organizations ranging from early-stage biotech companies to global pharmaceutical organizations and their service providers.
Clients engage me when they need experienced, independent support in areas where regulatory expectations, operational complexity, and business risk intersect.
GxP Quality was established to provide practical, high-value quality and compliance support tailored to the needs of modern life science organizations, particularly those operating with lean internal teams and outsourced models.
I support biopharmaceutical companies and service providers in ensuring the quality and integrity of clinical studies, safety programs, and regulated systems by designing and implementing effective, inspection-ready quality frameworks.
My approach is grounded in real-world experience. Quality systems are designed not only to meet regulatory expectations, but to function effectively in day-to-day operations without unnecessary complexity or administrative burden.
There is no one-size-fits-all model. Each engagement is tailored to the organization’s stage of development, risk profile, and operational structure, ensuring the right level of support from strategic oversight to detailed execution.
ABOUT MY COMPANY
MY APPROACH
I work closely with clients to understand how their systems, processes, and vendors operate in practice. This allows me to provide targeted, practical solutions rather than theoretical recommendations.
My focus is on:
Identifying and addressing compliance risks early
Designing systems that are both compliant and sustainable
Supporting teams in preparing for and managing regulatory inspections
Providing clear, actionable guidance that can be implemented efficiently