GxP Auditing
RiverArk delivers independent, risk-based GxP Auditing services designed to assess, stress-test, and strengthen quality systems across the product lifecycle.
Our senior auditors operate at inspection level, providing deep-dive audit diagnostics, real-time insight, and actionable remediation strategies across GCP, GVP, GLP, GCLP, GMP, GDP, and computer systems.
We are typically engaged when the regulatory inspections are imminent, the critical findings require remediation, the quality systems are scaling rapidly and when independent audit assurance is required.
Our approach goes beyond checklist auditing. We deliver risk-based audit planning and execution, data integrity and compliance assessments, inspection-grade audit reports and deliverables and targeted CAPA and remediation support
RiverArk enables organisations to move from reactive compliance to proactive inspection readiness, ensuring confidence under regulatory scrutiny.
GCP
RiverArk provides expert GCP auditing across all phases of clinical development, supporting global studies with inspection-ready quality assurance and compliance oversight.
Our auditors bring deep operational experience in clinical trials, enabling rapid identification of data integrity risks, protocol deviations, and systemic quality gaps.
We support:
- Sponsor and CRO audits
- Investigator site audits
- Vendor and system audits
- Clinical trial inspection readiness
Our risk-based, audit-led approach ensures alignment with ICH-GCP E6 (R2), FDA, EMA, and MHRA requirements, while strengthening clinical quality systems and regulatory compliance.
GVP
Our pharmacovigilance (PV) QA oversight functions as an integrated quality assurance (QA) and risk intelligence layer, rather than standalone auditing activity. Each pharmacovigilance audit combines structured review with broader risk assessment and regulatory compliance insight, ensuring findings are aligned with overall system performance.
Here, we don’t conduct isolated reviews, but we connect data integrity, process vulnerabilities, and organisational risk exposure with their regulatory and operational impact. This enables in-house QA teams to prioritise remediation based on true compliance risk, improving decision-making and efficiency.
Led by experienced GVP auditors, our services support FDA, EMA, and MHRA expectations, strengthening inspection readiness, PV system compliance, and long-term pharmacovigilance quality systems across the life sciences industry.
GLP / GCLP
Our experts at RiverArk bring deep expertise in OECD GLP principles, delivering comprehensive GLP audits across facilities, processes, study data, and reports, supporting central and bioanalytical laboratories in line with GLP and GCP requirements.
Our audits go beyond basic compliance, covering equipment qualification, method validation, data integrity (including ALCOA+), and study conduct to ensure accuracy, traceability, and regulatory alignment.
We specialise in complex laboratory environments, including multi-site studies, diverse analytical platforms and hybrid GLP/GCP settings. We also assess global outsourcing models and both legacy and modern data systems.
By identifying risks and gaps early, we provide practical, actionable insights that strengthen data integrity, support compliance, and improve inspection readiness.
GMP And GDP
At RiverArk, our experienced auditors provide expert Good Manufacturing Practices (GMP) auditing services, supporting both compliance and validation requirements. We also bring strong expertise in Good Distribution Practice (GDP), covering activities from raw material sourcing to final product distribution.
Aligned with EU GMP guidelines, USA cGMP regulations, and ICH Q7, RiverArk delivers flexible, global GMP/GDP auditing solutions. We also support pharmaceutical companies by monitoring supply chain complexity and overall inspection risk. RiverArk experts add value to any multi- site audits and ensure that quality standers are maintained.
Computer Systems / IT Audits
RiverArk delivers independent computer system audits and validation support, ensuring compliance with 21 CFR Part 11, EU Annex 11, and global data integrity requirements. We combine technical expertise with audit insight, enabling organisations to strengthen digital quality systems, ensure regulatory compliance, and maintain inspection readiness.
We offer comprehensive computer system validation audits to pharmaceutical, biotechnology and life sciences organisations with a practical approach to validation documents and activities and Data integrity assessments. Our experts also integrate seamlessly with client teams and support with system and vendor audits, ongoing validation and provide validation lifecycle support.
