GxP Audit Services
As global industry experts, Apotech partners with life sciences organizations around the world to streamline quality processes, mitigate risk and meet complex regulatory expectations. Our GxP audit services help biotech and pharmaceutical companies maintain compliance with ICH guidelines and global health authority standards, including the FDA, EMA, and MHRA.
For companies seeking a trusted partner in GxP auditing, we deliver clear insight, reduced risk, and enhanced inspection readiness. With a modern and dynamic approach, we deliver complete regulatory peace of mind and confidence in your compliance.
Overview of our GxP audit services
GxP audits provide a structured, independent assessment of systems, processes, and vendors to verify compliance with Good Practice regulations, including GCP, GLP & GCLP, GVP, GMP/GDP, and CSV. Our audits help ensure product quality, data integrity, subject safety, and operational control across the R&D, manufacturing, and distribution lifecycle.
A robust GxP audit program minimizes compliance risks, identifies operational gaps early, and prepares organizations for global regulatory inspections. For more information, read our article about GxP compliance and best practice.
Global complexity, simplified locally
Why GxP compliance matters
Undetected compliance gaps can lead to regulatory findings, warning letters, or data integrity issues.
For example:
- Inefficient or undocumented processes increase operational and quality risks.
- Vendor oversight is a regulatory expectation; insufficient qualification introduces supply chain vulnerabilities.
- Delayed remediation can result in costly corrective actions, audit postponements, or program disruptions.
GxP auditing services
At Apotech, we empower life sciences companies and manufacturers to achieve operational excellence through a full suite of GxP auditing services. We design, execute, and manage audit programs aligned with global regulatory expectations, including FDA, EMA, MHRA, and ICH requirements.
Our auditing coverage spans GCP, GLP & GCLP, GVP, GMP/GDP, and CSV, enabling organizations to qualify and requalify vendors, prepare for regulatory inspections, and uphold the highest standards of product quality, data integrity, and patient safety.
Whether you require end-to-end audit program oversight or targeted, one-off audits, we bring the technical expertise and strategic insight needed to drive compliance and continuous improvement across the product lifecycle. From ensuring the integrity and ethical conduct of clinical trials to reinforcing the reliability of laboratory and manufacturing data, our team streamlines the auditing process to deliver complete regulatory confidence.
GCP Audit Services
GCP audits are a critical part of the quality assurance framework in clinical trials for both medicinal products and medical devices. If your internal resources are limited, Apotech can help.
We maintain a strong understanding of the latest GCP requirements to ensure compliance and minimize regulatory risk. Our experienced auditors are equipped to evaluate whether organizations meet GCP standards and to conduct comprehensive, end-to-end GCP audits across the full clinical development lifecycle.
This includes assessments of investigator sites, CROs, vendors, systems, and trial documentation for compliance with ICH E6 and global regulatory expectations.
Whether conducted remotely or on-site, our audits are performed by highly qualified GCP auditors who can independently assess CROs selected to conduct clinical trials or evaluate the conduct of ongoing studies.
Apotech helps sponsors and CROs maintain high-quality trial execution, proactively manage risk, and stay inspection-ready from study start-up through closeout.
Key Audit Services:
- Investigator Site Audits
- System Audits
- Vendor Audits
- Documentation Audits
- Process Audits
- Inspection Readiness
Discover more about our GCP Audit Services
Good Laboratory Practice (GLP / GCLP) Audit Services
Maintaining Good Laboratory Practice (GLP/GCLP) is essential for life science laboratories and research facilities to ensure regulatory compliance, scientific rigor, and the credibility of the data produced. Our specialized GLP and GCLP audit services are designed to strengthen data integrity and reinforce confidence in laboratory outputs across complex research environments.
We evaluate preclinical facilities, analytical laboratories, and critical study processes to assess compliance, enhance operational quality, and support reliable, reproducible nonclinical research. Our team provides comprehensive insights into laboratory systems, documentation, and processes to help you unlock the full potential of your laboratory operations.
Key Audit Services:
- Study Audits
- Facility Inspections
- Critical Phase/Process Audits
- Data & Documentation Audits
- Study Report and Raw Data Reviews
- Archive Audits
- Animal Laboratory Audits
Good Pharmacovigilance Practice (GVP / GPVP) Audit Services
Marketing Authorization Holders (MAHs) are required under pharmacovigilance regulations to perform audits of their pharmacovigilance systems, using risk-based methodologies to evaluate the effectiveness of their quality frameworks. As described in GVP Module I, a GVP audit is a structured, independent, and documented process designed to gather and objectively assess evidence to determine whether audit criteria are met. This process strengthens risk management, controls, and governance across the pharmacovigilance system.
Our GVP audits provide clear visibility into the performance, compliance, and resilience of global pharmacovigilance operations. We evaluate the implementation and functioning of PV systems, including core safety processes, quality frameworks, partner oversight, affiliate activities, and patient-facing programs, to ensure alignment with regulatory expectations and best practices.
With extensive experience supporting both domestic and international clients, we are a trusted partner for organizations seeking to outsource their GVP auditing needs.
Key Audit Services:
- Pharmacovigilance System Audits
- Partner & Third-Party Audits (including distributors)
- Medical Information & Call Center Audits
- Program Audits (PSP, MRP, CUP, REMS)
- Specialty Pharmacy Audits
- Affiliate & Local Operating Company Audits
- QPPV / LSO Oversight Audits
- Internal Process Audits
- PASS & Post-Authorization Safety Study Audits
Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP) Audit Services
Manufacturers of drug substances and drug products are required to comply with Good Manufacturing Practice (GMP) regulations, which are verified through routine GMP audits. These audits assess whether manufacturing, quality control, and warehouse operations conform to the standards outlined in the Pharmaceutical Quality System and applicable global regulations.
GMP assessments typically include detailed reviews of manufacturing processes, quality control procedures, personnel practices, raw material oversight, outsourced activities, deviation and complaint handling, self-inspection, product recall processes, and more. Additional GMP guidelines may apply specifically to Active Pharmaceutical Ingredients (APIs) and to medicinal products used in clinical trials.
For medicinal product manufacturing sites, GMP compliance is confirmed through a Manufacturing and Import Authorization (MIA) and/or a GMP certificate issued by a Competent Authority. Active substance manufacturers, including intermediates, rely on a Qualified Person (QP) declaration to attest to GMP compliance.
Apotech can support both needs: we provide on-site manufacturing audits conducted by our QP as well as evaluations of external audit reports to confirm GMP adherence.
With extensive experience conducting audits worldwide, our team has helped numerous organizations implement robust GMP principles and achieve successful outcomes in regulatory inspections.
Our comprehensive GMP and GDP audit services evaluate the quality, compliance, and operational integrity of manufacturing, testing, storage, and distribution activities across APIs, investigational materials, commercial products, and the supply chain partners that support them.
Key Audit Services:
- API & IMP Manufacturing Audits
- Contract Manufacturing Organization (CMO/CDMO) Audits
- Storage & Distribution Center Audits
- Test Laboratory Audits
- Records & Documentation Audits
Computer System Validation (CSV) & Data Integrity Audit Services
Our Computer System Validation (CSV) and data integrity audit services ensure that computerized systems comply with global regulatory requirements and industry best practices, including Annex 11, 21 CFR Part 11, and established data integrity frameworks. These audits help verify that systems are accurate, consistent, reliable, and capable of performing as intended in a controlled and predictable manner.
We conduct thorough evaluations of system lifecycle documentation, validation planning, testing protocols, digital workflows, and data governance controls. Our assessments strengthen data integrity, ensure audit-readiness, and enhance confidence in the digital systems that support GxP operations.
Apotech’s CSV experts assess software suppliers, IT service providers, system governance structures, and GxP data processes to ensure that your digital ecosystem meets the highest compliance standards.
- Key Audit Services:
- Software Supplier Audits
- Electronic Records & Signatures Compliance Audits
- Infrastructure & IT Service Provider Audits
- Statistics, Programming & Data Processing Audits
- GxP System Audits
- Internal Process & Governance Audits
Our process
At Apotech, we take a modern, flexible approach to auditing, offering both comprehensive audit program oversight and individual audits on demand. Our global network ensures each audit is delivered by a consultant with the right technical background and regional regulatory expertise.
1. Scoping and needs assessment
Our Business Managers align with your compliance goals, timelines, and audit requirements.
2. Auditor assigned
We assign the most suitable expert based on GxP discipline, industry experience, and regional knowledge.
3. Audit preparation
Your auditor prepares the audit plan, agenda, and documentation request list and communicates with the Auditee to finalise.
4. Audit execution
The audit is conducted onsite or remotely, including interviews, documentation review, and assessment of systems, processes, or facilities.
5. Audit reporting
Following either your internal templates or our own custom template, you will receive a detailed report outlining observations/findings and narrative insights.
6. Follow-up and ongoing support
We remain available for clarification, CAPA support, follow-up audits, or ongoing monitoring.
Trusted by top-tier teams worldwide
Audits conducted in the last year
Network of expert GxP auditors
Countries covered
Why choose Apotech for GxP audit services
At Apotech, our onsite or remote audits help pharmaceutical, biotechnology and medical device companies maintain the highest standards of quality and safety. Thanks to our in-house auditing experience, we provide tailor-made solutions that you can trust.
Global GxP Specialists
Our network of 800+ senior auditors covers all GxP disciplines worldwide, providing tailored guidance with local-language fluency.
Regulatory and technical expertise
Our auditors bring real-world experience in biotech, pharmaceutical development, and CROs, paired with up-to-date knowledge of ICH, FDA, EMA, MHRA, and other global guidelines. With a minimum of 20 years of experience, they have individually led over 100 audits for various companies across the life sciences sector.
We provide competitive pricing
Our local auditors help minimise travel and expense costs, keeping our services cost-effective
Flexible, client-centred service
We offer scalable, tailored GxP audit solutions, from single vendor audits to fully outsourced global programs, adapting to your timeline, scope, and budget. Our dedicated Business and Project Manager model ensures seamless communication, scheduling, and consultant alignment.
Our Global Reach
We take pride in our extensive global audit network and are committed to utilising local auditors based in-country.
This approach offers several key benefits: local auditors possess in-depth knowledge of regional regulations, communicate effectively in the local language, and help reduce travel expenses for our clients. We have successfully provided support in all the regions highlighted on the map below.
Featured case studies
GMP Audits
GMP Audits Introduction UK Based Biotech The company is a worldwide large biotech with a vast portfolio of biotech products (mainly oncology). Apotech auditors: 3 auditors are involved in this partnership. Types of Audits Contracts/agreements between the clients and the provider GMP/GDP Client SOPs Local regulations Audit Locations Europe The audited sites are: Client manufacturing…
GxP Audits – Worldwide
GxP Audits – Worldwide Introduction Global Biopharmaceutical Our client is a global biotechnology company dedicated to novel treatments for patients through inhibition of protein kinases to fight cancer. They are Headquartered in the US, with a large footprint in the EU. Types of Audits GCP – For Cause / Investigator / Phase 1 unit GCLP – Central…
GCP Mock inspections – Europe
GCP Mock inspections Europe Introduction Danish R&D Pharmaceutical Company Our client is a pharmaceutical company committed to ensuring compliance with global regulatory standards, particularly FDA requirements for clinical trials Apotech auditors Our Auditors have 20+ years’ experience, all based locally with extensive experience in FDA inspections and GCP compliance. Collectively conducted over 50 regulatory inspections…
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FAQs on Audits
We provide a modern approach to auditing that offers full transparency. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
GxP audit services assess an organisation’s compliance with relevant Good Practice standards, including GCP, GVP, GLP, GMP, and GDP, with a focus on distribution and data integrity where applicable. These audits evaluate processes, systems, and documentation to identify compliance gaps, verify the effectiveness of quality management systems, and ensure readiness for global regulatory inspections.
Helpful resources
GxP Compliance Explained: Beyond Best Practice
Understanding the meaning of GxP is essential for any organization operating in the life sciences sector. In simple terms, GxP refers to “Good Practice” quality and regulatory guidelines, used to ensure products are safe, effective, and reliable throughout their lifecycle. These standards apply across pharmaceuticals, biotechnology, medical devices, and laboratory environments, and are enforced by…
Compliance, standards and quality assurance
Apotech operates in alignment with ICH , ISO standards, GxP requirements, and expectations from global regulators including FDA, EMA, and MHRA. All engagements maintain independence, objectivity, and confidentiality.
Data protection and confidentiality
We apply strict data protection measures, GDPR-aligned processes, and secure communication protocols to safeguard sensitive information throughout the audit lifecycle.
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