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 records of conducting around 300 on-site and remote audits across USA, Europe and APAC countries. People Leader, having managed a multinational Quality Assurance department of staff members across USA, EU and APAC regions. Lead and Co-Facilitator of 115 GCP regulatory inspections (FDA, EMA, MHRA, PMDA, other country / region local Health Authorities) in Europe and APAC (in-house, on-site, remote). Accomplished presenter at numerous Clinical Research Associates (CRAs) and Investigator Meetings, representing Clinical Quality Assurance.
Our Services
Clinical Quality Assurance (GxP) services
(in-house, on-site and remote) for Pharma, Biotech Companies and Contract Research Organizations
GCP Consultancy
(QMS concept / procedures development, review and implementation, Quality by Design Concept and Risk management, Gap analysis)
Investigator Site audits
Investigator Site audits
GCP, GDP, GVP Vendor audits
GCP, GDP, GVP Vendor audits
Trial Master File
Trial Master File
CSR Audits
CSR Audits
Process audits
Process audits
Protocol audits
Protocol audits
MDD / MDR audits
MDD / MDR audits
GCP Regulatory Inspections preparation and follow-up
GCP Regulatory Inspections preparation and follow-up
Inspection Readiness
Inspection Readiness
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