At MedGXP Consulting, we support clinical-stage pharmaceutical and biotechnology companies in achieving robust Good Clinical Practice (GCP) compliance and quality assurance across their development programs.
As medical doctors, we bring a unique perspective to QA — we understand the clinical realities behind protocol design, endpoint selection, and safety assessments. This enables us to better align with investigators, anticipate clinical challenges, and ensure quality systems are not only compliant, but also practical and patient-focused.
Whether you're preparing for a regulatory inspection, a sponsor audit, or building a fit-for-purpose Quality Management System (QMS), we deliver pragmatic, risk-adapted solutions tailored to your development phase and therapeutic area.
This is backed by a genuine track record. Our founder, Dr. Sergey Muzykantsky, brings over 24 years of experience in the pharmaceutical and clinical research industry, including 19+ years in quality assurance and more than 10 years as an independent consultant. His background spans senior QA roles within large pharmaceutical and biotech organizations, alongside work within several of the world's top 10 CROs. He has personally conducted more than 400 GCP compliance audits across the EU, US, UK, Africa, and Australia, led GCP Quality Management System redesigns aligned with ICH E6(R3), and supported regulatory inspections by the FDA and EMA. He is a Research Quality Association (RQA) member since 2012 and a Certified GCP Auditor.
The same three phases the audit itself follows — before, during, and after — shape how we work with every client.
Scoping the audit against the trial's risk profile, regulatory requirements, and your specific concerns before a single document is reviewed.
On-site or remote review of documentation, processes, and interviews — assessed with both procedural and clinical rigor.
A clear findings report, CAPA guidance, and support through remediation until the gap is genuinely closed.