ABOUT THE COMPANY
The QARP is an international network of independent auditors, QA consultants, and trainers in Clinical Trials
The QARP’s mission is to empower small and midsize pharmaceutical and biotech companies, research institutions, and CROs. We ensure success through independent process and systems evaluation, inspection readiness, regulatory compliance, and efficient training.
THE QARP’s CORE SERVICES are:
  • 1
    Auditing
    We offer specialized auditing across GCP, GCLP, GDP, GLP, and CSV, ensuring strict adherence to SOPs and protocol requirements to minimize risk and ensure consistency.
    Our global network of experienced, multilingual auditors, including former FDA inspectors, brings deep expertise to your projects. Each audit includes a detailed report with actionable recommendations to enhance compliance and operational effectiveness. A dedicated Project Manager and QA expert will guide you through the entire process, from planning to CAPA handling and closure, ensuring precision at every step
  • 2
    Consulting
    We specialize in the design, development, and implementation of tailored QMS solutions. We assist in creating, reviewing, and refining your QMS, ensuring it aligns with the latest industry standards and regulatory requirements. We offer expertise in drafting and reviewing Standard Operating Procedures (SOPs), helping you maintain a high level of operational integrity. Our consulting services extend to risk management, audit program development, and CAPA (Corrective and Preventive Action) management. Additionally, we provide strategic guidance for inspection readiness, ensuring your organization is always prepared for regulatory scrutiny.
  • 3
    Training
    The QARP offers targeted training programs designed to keep teams up-to-date with the latest regulatory standards and best practices in GCP, GCLP, GDP, GLP, and CSV. These interactive sessions are led by experienced professionals and are tailored to the specific needs of each organization, ensuring that staff are fully equipped to maintain compliance and operational excellence
  • 9 +
    years of experience in the international clinical trials market (since 2015)
  • 1400 +
    prepared and delivered trainings and workshops
    in Clinical Trial area
  • 900 +
    conducted audits
    in various GxP areas worldwide
  • 16 +
    pre-inspection audits
    and FDA, EMA and local inspections hosting
  • 9 +
    years of experience in the international clinical trials market (since 2015)
  • 1400 +
    prepared and delivered trainings
    and workshops in Clinical Trial area
  • 900 +
    conducted audits
    in various GxP areas worldwide
  • 16 +
    pre-inspection audits and FDA, EMA and local inspections hosting
  • 9 +
    years of experience in the international clinical trials market (since 2015)
  • 1400 +
    prepared and delivered trainings
    and workshops in Clinical Trial area
  • 900 +
    conducted audits
    in various GxP areas worldwide
  • 16 +
    pre-inspection audits and FDA, EMA and local inspections hosting
The QARP’s Geographic Coverage and Country-Specific Expertise
Western Europe
including:
  • Austria
  • Belgium
  • Spain
  • Germany
  • France
  • Italy
  • Netherlands
  • UK
  • Sweden
Eastern Europe including:
  • Poland
  • Czech Republic
  • Slovakia
  • Romania
  • Bulgaria
  • Hungary
  • Belarus
  • Georgia
The QARP’s Geographic Coverage
and Country-Specific Expertise
Western Europe
including:
  • Austria
  • Belgium
  • Spain
  • Germany
  • France
  • Italy
  • Netherlands
  • UK
  • Sweden
Eastern Europe including:
  • Poland
  • Czech Republic
  • Slovakia
  • Romania
  • Bulgaria
  • Hungary
  • Belarus
  • Georgia

The QARP Managing Core

  • Maxim Bunimovich
    CEO, Founder & Auditor, MD, MRQA, SQA
    Spain
    • 19 years in the pharmaceutical industry
    • 16 years in Clinical Trials
    • 13 years in QA
    • Specialty in Site, TMF and CRO audits
  • Oleg Shevaldyshev
    GCP Auditor, Quality and Training Director
    MD, MRQA, MCC Champion
    • 21 years of experience in the clinical research industry, including roles in Monitoring, Project Management, and Quality Assurance (QA)
    • QA interests include global non-compliance and serious breach management, issues/risk management, process management/improvement, and auditing.
  • Stanislav Praslov
    Auditor, MD, RQAP-GCP, MRQA
    Germany
    • 20 years in Clinical Research
    • 7 years of international auditing and QMS development experience
    • Consulting of operational teams on complicated GCP items
    • Vendor selection and CRO oversight audits
  • Valeria Sokolova
    BD Director
    • 8 years in Clinical Trials Industry
    • Proven Leadership in Business Development(6 years)
    • Client Relationship Management
    • Quality Assurance Expertise
    • Operational Excellence
  • Elena Efimova
    Training Manager, MEd, PM
    Spain
    • 20+ years in education & training
    • L&D consultant
    • Expertise in project management and process improvement
  • Elena Antonik
    Project Manager
    Germany
    • Over 9 years of experience in clinical research
    • Registered Good Clinical Practice (GCP) professional
    • Expertise in coordinating clinical trials, business development, and quality assurance processes
    • Skilled in project management
  • Julia Isakova
    Project Manager, PharmD
    Poland
    • Over 14 years in clinical research
    • Over 9 years in project management
    • Good Clinical Practice (GCP) professional
    • Expertise in Medical Writing, Bioinformatics, and CLinical Trials administration
    • Skilled in SOPs development and implementing
CONTACT US
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