Dr. Marek Wasiluk is a medically qualified and ISO 9000:2001 trained clinical research professional with over 25 years of experience, including 20 years in GxP auditing and quality consultancy. An expert in ICH GCP, QMS implementation, and global clinical regulations, he has conducted over 250 audits and consulting projects across 50 countries. His experience spans all clinical trial phases, FDA/EMA mock inspections, and risk-based global audit programs. Dr. Wasiluk specializes in vendor qualification, due diligence, and process optimization. He is also an ICH GCP trainer and business coach for senior management in pharma, biotech, and CRO organizations.