GCP & GLP Audits
Audits of sponsors, CROs, investigator sites, laboratories, vendors, systems and clinical documentation.
Our Team
Senior GxP Leadership Supported by an International Expert Network
GxP Auditing & Advisory is led by Dr. Alexandru Sirbu, Founder, CEO and Lead GxP Auditor. Depending on project scope, additional independent specialists may be engaged across regulated quality, clinical research, inspection readiness and compliance.
23+ Years
International clinical research, quality assurance and
regulatory compliance experience
EMA
Former EMA-certified GCP and GLP Inspector
WHO
Former WHO-appointed GCP and GLP Inspector
Global
Experience across sponsors, CROs, sites, laboratories,
HRPPs and research institutions
Founder · CEO · Lead GxP Auditor
Regulatory inspection experience translated into practical quality strategy
Dr. Alexandru Sirbu is a senior GxP auditor, regulatory advisor and clinical research quality leader with more than 23 years of international experience across Good Clinical Practice, Good Laboratory Practice, inspection readiness, quality management systems, CAPA, vendor oversight and human research protection.
He previously served as an EMA-certified GCP and GLP Inspector and as a member of the EMA GCP Inspectors Working Group. He was also appointed by the World Health Organization as a GCP/GLP Inspector for international inspection and evaluation assignments.
Dr. Sirbu was one of three international inspectors involved in the evaluation of the Republic of Korea under the WHO Listed Authority program.
His professional experience includes regulatory inspection, independent auditing, clinical quality assurance, research governance, HRPP oversight, AAHRPP readiness, QMS implementation, SOP development, CAPA planning, training and inspection-readiness support.
Core areas of expertise
Senior-level support across regulated research and quality systems
Inspection Readiness
Mock inspections, readiness assessments, interview preparation and regulatory inspection support.
HRPP & AAHRPP
Research governance, IRB oversight, accreditation readiness and human research protection frameworks.
CAPA & Remediation
Root cause analysis, CAPA design, effectiveness verification and remediation following significant findings.
QMS & SOP Development
Quality system development, SOP architecture, deviation management and continuous improvement.
Training & Executive Advisory
GxP training, inspection coaching, QA mentoring and executive-level quality advisory.
Selected experience
A career across inspection, auditing and clinical research quality
2025-2025
Research Quality, Compliance & HRPP Leadership
Integrated healthcare and research environment, UAE
Research quality leadership, HRPP governance, AAHRPP readiness, IRB oversight, QMS implementation, internal audits, SOP development and regulatory training.
2022–2025
GCP & GLP Expert Co-Inspector
World Health Organization
International inspections and regulatory-system evaluation activities involving clinical studies, CROs and quality-control laboratories.
2019–2022
Senior GCP Auditor
Boehringer Ingelheim Pharma GmbH
Audits of investigator sites, TMFs, databases, study reports, systems, vendors and computerized systems, including pre-inspection activities and CAPA evaluation.
2014–2016
GCP & GLP Inspector
Medicines and Medical Devices Authority
Planning and execution of GCP and GLP inspections, inspection SOP development and participation in the EMA GCP Inspectors Working Group.
2003–2014
Clinical Research & Clinical Operations
CROs, sponsors and clinical research organizations
Clinical trial monitoring, regulatory submissions, site management, feasibility, training, quality control, pre-inspection work and clinical operations management.
Extended capability
Supported by an international network of independent specialists
Dr. Sirbu is the sole public-facing lead auditor and executive advisor. Depending on the complexity and technical scope of an assignment, additional independent specialists may be engaged.
Specialist expertise available across the GxP lifecycle
The extended network provides access to senior expertise across regulated quality, clinical research, laboratory compliance, pharmacovigilance, computerized systems, data integrity, manufacturing, distribution, research governance and inspection readiness.
Collaborators are selected according to project requirements,
technical expertise, availability and potential conflicts of interest.
Their identities and roles are disclosed only during project scoping,
where appropriate. References to EMA, FDA, WHO, MHRA or other
authorities describe relevant regulatory experience and do not imply
endorsement or official representation.
Confidential senior-level advisory
Discuss Your Audit, Inspection Readiness or Quality System Requirements
Engage directly with the lead auditor to discuss your regulatory context, current risks and the expertise required for your assignment.
Schedule a Confidential Discovery Call