A global network of expert auditors, trusted by sponsors who care about quality.

It’sQA Associates is an ISO 9001-certified clinical quality consultancy delivering independent GxP audit and QA services across the life sciences, including pharma, biotech, CROs, medtech, and clinical software.

We specialise in clinical research across all GxPs (GCP, GMP, GLP, and CSV), with a deep bench of freelance auditors who’ve worked on the front lines of regulatory inspections. For over two decades, our model has combined senior expertise, agile delivery, and strategic insight; helping clients stay audit-ready while navigating complex compliance demands.

Whether you need full QA support or a single specialised audit, our team works with precision, transparency, and a focus on long-term partnership.

What We Do:
✔ Global GCP audits (onsite and remote)
✔ Vendor qualification and oversight
✔ QA consulting across GCP, GMP, GLP, CSV
✔ SOP development, QMS design and CAPA systems
✔ Regulatory inspection support and remediation
✔ Therapeutic expertise across CNS, oncology, immunology, cardiovascular, rare disease and more

Our auditors have delivered thousands of successful audits across Europe, North America, Asia, Latin America, and Africa;  including virtual audits during COVID-19 and ongoing hybrid inspection-readiness models.

Who We Work With:
•	Sponsors: pharma, biotech, medtech
•	CROs and clinical operations teams
•	SaaS and healthtech innovators
•	QA leads seeking audit capacity or temporary coverage

Why Clients (and Auditors) Choose Us:
•	20+ years of proven QA leadership
•	Transparent, human-first partnerships
•	Global network of experienced freelance auditors
•	Tailored, inspection-ready systems and strategy
•	ISO certified and inspected since 2005

It'sQA Associates Limited

Org chart

Teams

Offices