Precision to the last detail

GXP Engaged Services

After implementation of the Directive 2001/20/EC and as specified in article 16 of the Common Directive 2005/28/EC, Quality Control and Quality Assurance are a legal requirement for sponsors.

Audits follow the standards of ISO 19011 and the ENGAGE Optional Guideline for compliance and Quality Systems Auditing from the European Network of GCP auditors and other GCP experts.

These stipulate that all audits follow a defined audit plan. The audit plan for a contracted audit is always peer-reviewed and released from the lead auditor and the audit client, reflecting that the scope and objectives of the audit are agreed to and the areas to be addressed are known and accepted by both, in advance. Results of the audit are communicated in peer-reviewed audit reports using either our own harmonized templates or templates from the client. Expedited reporting can be arranged for certain audit outcomes according to sponsor requirements and standards.

Inspection readiness programs are conducted according to published standards from regulatory authorities, referring to applicable standards.

Core Services

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Service Packages

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Auditing standards

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Countries covered

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