Good Laboratory Practice (GLP) Audit Services
GLP audits are essential for maintaining the integrity, reliability and regulatory compliance of nonclinical research, helping organisations evaluate whether studies and laboratory activities meet Good Laboratory Practice requirements and applicable regulatory expectations.
Tower Mains provides independent GLP audit services across the nonclinical research lifecycle, using a practical, risk-based approach to identify risks, strengthen oversight and support inspection readiness.
Our experienced auditors cover preclinical facilities, contract research organisations, laboratories, specialist suppliers, study documentation, data integrity and quality systems, providing clear findings and practical recommendations tailored to your needs.
Why GLP audits matter
A robust GLP audit programme helps organisations maintain confidence in nonclinical research data, strengthen laboratory quality systems and ensure studies meet regulatory expectations. Without appropriate GLP oversight, organisations may face:
Data integrity, documentation or traceability concerns
Inconsistent laboratory processes or quality system weaknesses.
Insufficient oversight of CROs, test facilities and specialist vendors.
Regulatory findings during inspections or study reviews.
Delays to research programmes and increased corrective action requirements.
Tower Mains helps organisations proactively identify and address these risks through independent GLP audits, providing clear insight and practical recommendations to strengthen laboratory compliance, data integrity and inspection readiness.
Our GLP audit services
Tower Mains provides flexible, risk-based GLP audits for pharmaceutical, biotechnology and research organisations throughout the nonclinical development lifecycle. Each audit is tailored to your requirements and aligned with GLP principles and applicable regulatory expectations.
Vendor audit
- Contract research organisations
- Pre-clinical facilities
- Contract laboratories
- Histopathology facilities
- Statistical facilities
- Archives
Test facility/sites
- Facility audits
- Process audits
- System audits
Study audit
- Study plan/amendments
- Critical phase
- Raw data
- Final report
Computer System Validation (CSV) audits
Our GxP audit process
Tower Mains applies a practical, risk-based approach to GxP auditing, ensuring each audit is delivered by a specialist with the appropriate technical expertise and regulatory knowledge.
1. Understanding your requirements
We begin by understanding your objectives, audit needs, timelines and key areas of focus.
2. Selecting the right GxP auditor
We assign an auditor with relevant GxP expertise, industry experience, technical knowledge and an understanding of your specific requirements.
3. Preparing for your audit
Your auditor prepares the audit plan, agenda and documentation requirements.
4. Conducting the audit
Audits are performed remotely or on-site through interviews, document reviews and assessment of relevant systems, processes, facilities, suppliers or studies.
5. Delivering clear audit outcomes
You will receive a comprehensive audit report, prepared using your preferred format or our own template, detailing observations, findings and practical recommendations for improvement.
6. Follow-up and ongoing support
Where required, we provide follow-up activities including CAPA review, re-audits and additional quality assurance support.
Why choose Tower Mains?
Global GxP Expertise
Access experienced auditors, quality professionals and subject matter experts across the GxP landscape, from clinical and laboratory environments to manufacturing, devices and research. We bring industry experience and specialist insight to help you address quality and compliance priorities.
Regulatory and Technical Insight
Our team brings extensive, real-world experience across global regulatory frameworks, including ICH, FDA, EMA and MHRA requirements. We help organisations interpret regulatory expectations, focus on what matters, assess risk and make informed quality decisions with confidence.
Flexible Quality Solutions
From single audits and annual audit programmes to vendor oversight, QA support and inspection readiness, we provide the right support for your objectives and risk profile. Services can be delivered in person, remotely or through a hybrid approach.
Practical. Proportionate. Collaborative.
We believe quality should enable your organisation, not add unnecessary complexity. Working alongside your teams, we bring an objective perspective, provide constructive challenge and help strengthen quality systems through sustainable improvements.