GXP Audits - EPiC

Your Road to Compliance & Integrity

Adhering to Good Practices (GXP) is more than a regulatory requirement; it is a cornerstone of trust, quality, and excellence. Our team of experts, specializing in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Pharmacovigilance (PV), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) audits, stands ready to equip your operations with the highest standards of compliance and integrity.

Comprehensive GXP Audit Services

We support your internal, corporate and supply chain audit programs, helping you meet your quality oversight obligations. All our audits are carefully planned and carried out, focusing on GXP compliance, risk management and process improvement. With decades of auditing experience our consultants bring unmatched expertise to your team.

Our audit services encompass:

Supply Chain Audits: we specialise in conducting thorough supply chain audits that cover every aspect of the product life cycle from starting material manufacturers, API manufacturers, excipient suppliers, packaging suppliers, clinical development, medicinal product manufacturers and contract manufacturers, EU importation and testing through to QP certification activities.
Due Diligence Audits: proving expertise to conduct suitability assessments of suppliers, service providers, or in relation to mergers and acquisition activities, these audits will rapidly identify potential issues and gaps in relation to current industry and regulatory standards.
‘For Cause’ Audits: targeted audits in response to an incident such as a recall, complaint or adverse regulatory inspection finding, providing expert guidance to implement mitigating actions and effective CAPA.
Corporate GXP Audits: providing expertise and resource to support corporate audit programmes covering the full range of site or corporate function operations, assessing their compliance with internationally recognised GXP standards.

Why Choose EPiC for Your GXP Audits?

Ex-Regulatory Consultants: Our team is composed of former regulatory agency consultants, bringing insider knowledge and perspective to your audits. This unique background enables us to anticipate compliance concerns and advise on best practices that go beyond basic compliance.

Tailored Approach: Understanding that each organization is unique, we do not believe in a one-size-fits-all solution. Our audits are customized to meet your specific needs, challenges, and goals, ensuring meaningful and actionable insights.

Commitment to Quality: Quality is not just a regulatory requirement for us; it is a principle we live by. Our audits are thorough, transparent, and aimed at fostering continuous improvement, ensuring you achieve and maintain sustainable compliance.

Next Steps

Contact us today to learn more about how our GXP audit services can benefit your organisation or to schedule a consultation with one of our expert consultants.

Let us help you navigate the complexities of regulatory compliance and safeguard product quality and patient safety.