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DO YOU NEED TO CONDUCT

A GXP AUDIT?

The QARP offers comprehensive support and expert guidance to biotech, pharmaceutical companies, CROs, and other healthcare organizations involved in drug development. Specializing in GxP and regulatory compliance, The QARP ensures adherence to global standards across various domains. With auditors located in Western and Eastern Europe, the USA, Latin America, India, Australia, China, and South Africa, we provide worldwide coverage, offering localized expertise and a global perspective to meet the regulatory needs of diverse regions.
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Our Auditors
With a global network of highly experienced auditors,
The QARP has conducted hundreds of audits worldwide, covering all GxPs and multiple therapeutic areas.
Our auditing support is scalable, ranging from conducting
a single specialized audit to full management and execution of a company’s entire annual audit plan.

THE QARP’s Auditors

  • Auditor, Consultant, MSc RAC/CQA CPGP
    USA
    • Former FDA investigator with extensive experience in conducting complex FDA inspections worldwide
    • Senior project manager with 20+ years’ experience in FDA-regulated medical product research & development
    • Skilled in coaching and preparation for FDA inspections
    • Experienced in oncology, vaccines, rare disease, medical device, and start-up biotech
  • 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
  • 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
  • Instructor & Auditor, MRQA
    UK
    • Expert QA auditor since 2007
    • ISO 9001:2015 Lead Auditor
    • Specialty in CSV and GCP
    • Training preparation and delivery for both GCP and CSV
  • Auditor, MRQA
    Warsaw
    • 9 years in QA and auditing
    • Background in Chemical Sciences
    • Specialty in GCLP and GLP audits
  • Auditor, RN, MSN, CCRP
    The USA
    • 15 years in GCP auditing
    • 20 years of experience in clinical research
    • Speciality in Risk Assessment and Process Improvement
  • Auditor, FACRP, ACRP
    South Africa
    • 16 years in QA and auditing
    • FDA Quality and Regulatory Consultant
    • Functional expertise in CQA, QMS, Process Improvement and Change Management
  • Auditor, MD, SQA USA, MRQA
    Turkey
    • 17 years in CTs, 10 years in QMS and 6 years in GCP auditing
    • CQI|IRCA certified Lead Auditor Quality Management System (QMS) ISO 9001:2015.
    • CERT certified ISO 9001:2015 Quality Manager and Internal Auditor (Quality Management System)
  • Auditor, FACRP, ACRP
    Bulgaria
    • 17 years in Clinical Research
    • 10 years in GCP auditing
    • Auditing consultancy – Leading GCP and GMP audits
    • Data Safety Monitoring Board (DSMB) member
  • Auditor
    Australia
    • 20 years in Clinical Research
    • 12 years in GCP/GMP/GVP auditing
    • Certified as a lead auditor for ISO 9001:2015
    • Skilled in risk management, CAPA development, root cause analysis, and SOP development
  • Auditor
    Argentina
    • 18 years in clinical research
    • 15 years in QA
    • Registered Good Clinical Practice (GCP) Clinical Quality Assurance (CQA) professional
    • Extensive knowledge of GCP, current industry practice, US Food and Drug Administration (FDA), European Union (EU) and Latin America.
  • Auditor, ACRP, RQA
    • Deep knowledge and experience in applying local and international requirements (EMA, MHRA, FDA) for conducting clinical trials
    • Proficiency in conducting audits according to ISO 9001:2015 standard methodology
    • Broad expertise in pharmacology and understanding of drug development process stages
  • Auditor
    Iceland
    • Extensive experience in planning, writing, and assessing clinical trial protocols and study reports for pharmacokinetic, BE , and efficacy studies.
    • Performed GCP audits and assisted sponsors in setting up GCP Sponsor Quality Management Systems (more than 7 years of experience)
  • Auditor, MPharmRS, MA, IMC, PCQI, MRQA
    Malta
    • Over 22 years of experience in GxPs QA Expertise
    • GCP, GVP, GMP, GDP Auditing
    • Quality Assurance
    • System Management
    • Regulatory Requirements Affairs
THE QARP’S AUDIT EXPERTISE

The QARP's auditing capabilities encompass a wide range of GxP areas, including GCP, GLP/GCLP, GDP, and CSV. Our audit services are not limited to specific types but cover the entire spectrum of GxP audits:

  • SITES
    Investigator sites (including Phase I and bioequivalence studies) and preclinical study sites across all therapeutic areas
    1
  • TRIAL MASTER FILE
    Comprehensive audits of Sponsor and/or Investigator Files, both in paper and electronic formats
    2
  • CONTRACT RESEARCH ORGANIZATIONS
    Audits midsize, and small CROs and Site Management Organizations (SMOs)
    3
  • Process Audits
    In-depth audits of Data Management, Archives, Project Management, Medical Writing, Vendor Management, Safety Processing, and Sponsor Oversight
    4
  • Systems Audits
    Assessment of computerized systems at any stage of development or implementation, including ePRO, Central Imaging, EDC, eCRF, DMC/EAC systems, eTMF, IXRS, eConsent, and eDiary
    5
  • CLINICAL TRIAL VENDORS
    Audits of pharmaceutical warehouses (IMP Depots), logistics companies, and local and central analytical laboratories
    6
  • Preparation for an Inspection (and Mock Inspection)
    The QARP’s experts possess unique experience in supporting organizations before and during inspections by international regulatory authorities, including the FDA and EMA. We provide comprehensive preparation services, ensuring that study sites and organizations are fully prepared for inspections in line with national and foreign regulatory requirements
    7
Proper audit preparation optimizes both the time and expenses associated with conducting an audit, ensuring thoroughness and compliance

Individual Audits

The QARP provides support with auditors who have the requisite skill set, GxP and regulatory expertise, geographical location, and language skills. We operate using our own internal SOPs and templates or the client's SOPs, templates, and platforms. All deliverables undergo internal peer Quality Check review before submission, ensuring the highest quality and accuracy. Additionally, we offer transparent, up-front cost estimations for all audit engagements

Audit Programmes

The QARP also offers the setup, management, and execution of part or all of your audit program. Our experienced in-house Project Managers oversee these programs, ensuring adherence to timelines, budget, and quality requirements. Drawing on a wealth of experience and best practices, our Project Managers have successfully managed numerous audit programs, ensuring smooth execution and comprehensive regulatory compliance
SUBMIT A REQUEST

Are you facing these challenges?

  • Managing and overseeing GxP audits within your organization
  • Developing and implementing a global audit program
  • Coordinating individual consultants across multiple studies worldwide
  • Creating and executing audit programs specific to each study
  • Allocating excessive time and resources to audit management

The QARP’s Solution:

We provide a streamlined, efficient audit management service designed to address these exact challenges:

  • Ensure Compliance: We ensure strict adherence to Standard Operating Procedures (SOPs) and protocol requirements in every audit we conduct, minimizing risk and ensuring consistency
  • Global Auditor Database: We have an extensive network of experienced, multilingual auditors, including former FDA professionals, who bring a wealth of knowledge and expertise to your projects
  • Dedicated Support Team: Benefit from a dedicated Project Manager and QA expert who will guide you through the entire audit process—from planning and execution to CAPA handling and closure—ensuring that every aspect is managed with precision and care
  • Expertise You Can Trust: Our auditors possess extensive experience across various regulatory landscapes and are equipped to handle the most complex audits, ensuring your organization is always inspection-ready
  • Risk-Based Audit Program: We work with you to develop and implement a risk-based audit program tailored to your specific needs, enhancing efficiency and reducing unnecessary burdens
  • Audit Coordination: We take the lead in coordinating all audits within your organization, streamlining processes and freeing up your internal resources to focus on core activities
  • Transparent Pricing: Our services are offered at a fixed hourly rate based on the auditor's expertise, providing you with clear and predictable costs without compromising on quality
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