
GxP Auditing
At RiverArk, we provide expert GxP auditing services to help pharmaceutical, biotechnology, and medical device companies ensure regulatory compliance, quality assurance, and risk mitigation across their operations. Our Good Practice (GxP) audits—including GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GDP (Good Distribution Practice), and GVP (Good Pharmacovigilance Practice)—are designed to meet the latest FDA, EMA, MHRA, and ISO standards. With a focus on data integrity, process review, documentary evidence, corroboration of data and regulatory preparedness, our team of industry specialists conducts independent audits, gap assessments, and compliance support to help clients navigate evolving global regulations. Whether you need pre-inspection readiness, supplier audits, or routine internal compliance reviews, RiverArk ensures that your business maintains the highest quality and regulatory standards in life sciences.

GCP
Our experienced team of auditors provide practical assessments and
advice towards any aspect of a clinical study. Identify potential risks and
ensures compliance issues addressed…
GVP
We also provide our clients with Pharmacovigilance (GVP) support, allowing them to ensure action is taken to reduce the risks and increase the benefits of medicines…


GLP / GCLP
Our team of consultants are here to help you boost the quality and readiness of your laboratory and organizations for GLP validation…
GMP And GDP
The wide span of expertise our team of consultants brings also covers Good Manufacturing Practice (GMP), helping our clients ensure products will meet the quality standards required for their intended use…


Computer Systems / IT Audits
Our team are equipped to provide our clients with exceptional CSV support for systems used throughout clinical development…
FAQs
What are GxP audit services?
GxP audit services involve a thorough evaluation of an organization’s compliance with Good Practice (GxP) regulations across areas like manufacturing (GMP), clinical (GCP), and laboratory (GLP) practices. These audits ensure that your processes meet industry standards and regulatory expectations.
Why is GxP auditing important?
GxP auditing helps identify potential compliance gaps, ensures product safety and efficacy, and prepares your organization for regulatory inspections. Regular GXP audits minimize business risk and enhance trust with clients and regulatory bodies.
What is included in GxP audit services?
GxP audit services typically include:
- On-site and remote audits
- Review of documentation and SOPs
- Staff interviews and process walkthroughs
- Detailed audit reports and corrective action plans
- Follow-up support to close findings
What industries require GxP consultancy?
Industries such as pharmaceuticals, biotechnology, medical devices, and clinical research often require GxP consultancy. These services ensure that your operations align with global regulatory standards, such as FDA, EMA, and ICH guidelines.
How often should a company conduct a GXP audit?
It’s recommended to conduct internal or third-party GXP audits at least annually or more frequently, depending on the nature and complexity of your operations. Risk-based scheduling is often used to prioritize audits.
What is GxP risk assessment?
GxP risk assessment is a structured process to identify and evaluate compliance risks in GxP-regulated environments. It helps prioritize remediation efforts and supports a proactive compliance strategy.
How can GxP consultancy help during regulatory inspections?
GxP consultancy firms provide expert guidance, mock inspections, and documentation review to ensure your team is well-prepared for regulatory audits. Their experience helps reduce audit findings and improve inspection outcomes.
Can I outsource GXP audit services?
Yes, many organizations choose to outsource their GXP auditing to specialized firms. This provides access to unbiased expertise, global regulatory knowledge, and cost-effective compliance solutions.
What makes a good GXP auditing partner?
A reliable GXP auditing partner should have:
- Certified and experienced auditors
- A proven track record in your industry
- In-depth knowledge of current regulatory expectations
- Comprehensive GXP services, from audits to training and risk assessment
How do I get started with your GXP services?
Simply contact us for a consultation. Our experts will assess your needs, define the scope of GXP audit services required, and help you develop a customized compliance plan.