The Team
Our consultants bring cross-functional experience across sponsor, CRO, investigator site, and regulatory landscapes - enabling practical, high-confidence guidance grounded in real operational realities
Andrew Makovetskyi
Founder & CEO
Independent GCP auditor and QA consultant with nearly 20 years of experience across global clinical research and pharmaceutical supply systems.
Has led GDP, GSP, GCP audits, inspection readiness programs, CAPA governance, and QA framework development, supporting sponsors, CROs, and public-health initiatives across Europe and CIS
+38 (067) 235-58-73
Yaroslav Sadovyj
Lead Auditor
Clinical quality assurance auditor with extensive experience in GCP oversight across CROs, investigator sites, and vendors.
Specializes in QMS development, SOP governance, CAPA management, and audit execution, supporting regulatory readiness and operational quality across clinical development environments
+38 (093) 486-84-81
Andrii Heneralchuk
Auditor
Quality Assurance auditor with extensive experience in GxP auditing across investigator sites, CROs, laboratories, and digital service providers.
Supports regulatory inspections, vendor qualification, CAPA oversight, and QA consultancy, helping organizations strengthen operational quality, data integrity, and inspection readiness.
+38 (095) 668-33-22
Alexa Iankova
Senior Auditor
Recognized expert in clinical trial oversight, with regulatory experience from the State Expert Center of the Ministry of Health of Ukraine leading national GCP audit and evaluation activities.
Has directed clinical trial auditing, regulatory review, and compliance programs, contributing to strengthened research governance and ethical standards in Ukraine through expertise, policy guidance, and professional training initiatives.
+38 (097) 907-56-87
