About the company

The QARP is an international team of coaching trainers, experts, and auditors in Clinical Trials
Of experience in the international clinical trials market (since 2015)
1400 +
completed Russian and English trainings and workshops in Clinical
Trial area
900 +

audits in various GxP areas worldwide (including site quality control visit)

pre-inspection audits and FDA, EMA and Federal Service for Surveillance
in Healthcare (Roszdravnadzor) inspections hosting

    Our goals

    The QARP goal is to develop an interactive platform for an open discussion regarding Clinical Trials and quality management aspects for experts. We perform trainings, workshops, and develop new educational techniques
    We have teamed up to improve educational principles and paradigms for experts
    Our competencies
    How can we be helpful?
    Organizing and conducting interactive trainings and seminars
    (remote and face-to-face, open and corporate)

    Organisation and performance of GxP audits, inspection readiness and follow-up from any inspection or audit in accordance ICH-GxP guidelines
    Consulting in development and maintenance of Quality Management System and Regulatory Affairs

    Our team
    • Maxim Bunimovich
      Independent international GCP auditor
      Maxim Bunimovich is an International GCP auditor, QA consultant, trainer with a considerable experience in audits and inspections of study sites in various countries worldwide
      (EU, CIS, Africa), as well as practical experience
      in development of quality management systems for CRO and sites (over 10 years of experience).
    • Alena Kulikova
      Expert, independent auditor and trainer in Good Clinical Practice, The QARP
      Alena Kulikova is a clinical trial expert who has
      a vast knowledge and practical experience in organisation, coordination, monitoring, quality verification, and audit of clinical trials, as well
      as training of all involved parties.
      She has significant experience in organisation and performance of trainings at the international level for hundreds of CT specialists throughout Europe and the Middle East.
    • Polina Gremyakova
      The QARP Expert in Good Clinical Laboratory Practice
      Polina Gremyakova is highly proficient in performance of laboratory audits, development and generation of quality management systems of laboratories performing analyses in clinical trials (GCLP). She is experienced in laboratory certification for conformity with GLP and ISO 9001:2015 requirements.
    • Dr. Hanna PreuS, MRQA
      Director, Clinical Quality Assurance (Global Process and Continuous Improvement Lead), Astellas Pharma
      • Global Quality & Compliance Expert, Auditor and Business Strategist
      • Quality Culture & Quality Management System
      • Operational Excellence, Process Compliance and Agile Project Management
      • Clinical Operations and Quality Strategy
      • Business Integration and Process Improvement
      • Broad experience in regulatory and GxP standards
    • Paul MacMahon, RQA
      Experienced Quality Assurance (QA)
      auditor since 2007 with experience in
      GLP/GCP CRO organisations working
      to both UK/EU and international regulatory
    • Sabrina Dey
      Is an experienced Quality Assurance professional covering both GCP and CSV
      Sabrina Dey is an experienced Quality Assurance professional, being highly proficient both in GCP and CSV. She has significant experience in the management of numerous QA activities including but not limited to: the conduct of GxP audits, training, and SOPs oversight and management.
    They trust us
    Contact us
    Ul. Adama Branickiego 21 U3
    Warsaw; Mazowieckie;
    Postal Code: 02-972