Validra Clinical Compliance Ltd

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Validra Clinical Compliance Ltd is an independent quality and compliance consultancy specialising in Good Clinical Practice (GCP) audits and audit-related support for Sponsors, CROs, and clinical and consumer product testing organisations.

We provide objective, risk-based audit services designed to support regulatory readiness, sponsor oversight, and continuous improvement, while remaining practical and proportionate to the activities being audited.

  Validra was established to provide independent, high-quality GCP audits that organisations can rely on with confidence.

We recognise that audits should do more than identify gaps — they should provide clear insight, proportionate findings, and practical direction, helping organisations strengthen their systems without unnecessary disruption.

 Validra supports organisations through:

• Independent GCP systems, site, and study-specific audits
• Sponsor-commissioned oversight audits of CROs and testing sites
• Remote, on-site, and hybrid audit delivery
• CAPA  eview, follow-up, and audit closure support

Our services are suitable for both routine quality oversight and targeted, risk-based assurance activities.

  Validra operates under a structured Quality Management System aligned with ISO 9001 principles, with audits conducted in accordance with ICH-GCP E6 (R2) and guided by recognised auditing principles.

Our approach is:

• Independent – auditor objectivity and conflict management are fundamental
• Risk-based – effort is focused where it matters most
• Transparent – clear scope, findings, and conclusions
• Pragmatic – proportionate recommendations that can be implemented

  Our audits are conducted by experienced GCP auditors with backgrounds in:

• Clinical research and CRO operations
• Quality assurance and compliance
• Sponsor oversight and audit readiness

Auditors are selected based on:

• Relevant  experience and competence
• Independence from the audited organisation
• Suitability for the audit scope and risk profile

  Independence is central to everything we do.

Validra maintains:

• Defined  conflict of interest controls
• Auditor independence declarations
• Clear separation between audit delivery and audit approval

This ensures audit outcomes are objective, defensible, and credible.

•   Sponsors commissioning independent GCP audits
• CROs and testing laboratories
• Quality and compliance teams
• Organisations seeking objective assurance of their GCP framework