Global Clinical Research & Quality Assurance Expert
Medical Doctor specialized in internal medicine and oncology, graduated from Odessa State Medical University in 1999. Over 25 years of extensive experience in clinical trials spanning clinical operations, medical affairs, and quality assurance across various therapeutic areas at pharma and contract research organizations.
Independent GxP Consultant (mainly GCP, GDP, GVP) with a proven track record of conducting around 300 on-site and remote audits across USA, Europe and APAC countries. People Leader, having managed a multinational Quality Assurance department across USA, EU and APAC regions. Lead and Co-Facilitator of 115 GCP regulatory inspections (FDA, EMA, MHRA, PMDA and other local Health Authorities) in Europe and APAC.
Our Services →
Our Services
Clinical Quality Assurance (GxP) services
In-house, on-site and remote QA services for Pharma, Biotech companies and Contract Research Organizations.
GCP Consultancy
QMS concept and procedures development, review and implementation, Quality by Design and Risk Management, Gap analysis.
Investigator Site audits
Routine and for-cause audits of investigator sites for GCP compliance, across USA, Europe and APAC.
GCP, GDP, GVP Vendor audits
Vendor and third-party audits covering Good Clinical, Distribution and Pharmacovigilance Practice.
Trial Master File
TMF completeness, quality and inspection-readiness reviews.
CSR Audits
Clinical Study Report audits for accuracy, completeness and regulatory compliance.
Process audits
Audits of clinical operations and quality processes to identify gaps and drive continuous improvement.
Protocol audits
Review of study protocols for GCP and regulatory compliance.
MDD / MDR audits
Medical Device Directive / Regulation audits for device and combination product trials.
GCP Regulatory Inspections preparation and follow-up
End-to-end support for FDA, EMA, MHRA, PMDA and other Health Authority inspections.
Inspection Readiness
Proactive readiness assessments and mock inspections ahead of regulatory visits.
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Have a question about an audit, inspection or GxP consultancy engagement? Get in touch and we will get back to you shortly.