Your trusted Partner in Regulatory & Compliance Audits
At Epiqure, we offer comprehensive GxP and compliance audits tailored to your needs — whether you're managing a clinical trial, qualifying a new vendor, or ensuring readiness for regulatory inspections. Our experienced team conducts audits across a wide range of entities involved in regulated environments.
Our auditing expertise spans the full spectrum of GxP-critical functions. We regularly audit:
CRO (Contract Research Organizations) & Study Centres
Vendors, Service & Software Providers
Distributors, Partners & Affiliates
CMO (Contract Manufacturing Organizations)
CDMOs (Contract Development Manufacturing Organizations)
Self Audits & Inspection Readiness Assessments
With a global network of 120+ industry experts, including former inspectors and specialists across all GxP domains, we are able to assign the right auditor to every audit based on its scope and location.
We follow a structured and transparent audit process to ensure clarity, compliance and collaboration at every stage:
Scheduling & Coordination
We liaise with the Auditee to define and confirm suitable audit dates.
Audit Agenda Preparation
A detailed agenda is drafted and aligned with both the Client and the Auditee for approval.
Pre-Audit Document Review
We analyze relevant materials such as previous audit reports, contracts, agreements, SOPs, and more.
Audit
Execution
The audit is conducted either onsite or remotely, in strict accordance with the approved agenda.
Audit Report
Preparation
A comprehensive report is delivered, detailing the audit activities, areas reviewed and any findings categorized in accordance with the Client’s procedures or EU GxP standards (Critical, Major, Other).
CAPA Support
(Upon Request)
If required, we assist in the development and review of Corrective and Preventive Actions (CAPAs), ensuring findings are properly addressed and followed through to resolution.