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Ensure quality and compliance before the official audit

Expertise field

Audit plan, findings, recommendations for improvement and report

Qserve provides mock audits, document reviews, practical solutions, checklists and internal audit programs to ensure your compliance. We are prepared, are you?



We can assist you with the following services

Internal Audit

Essential to continuously improve your process and essential for full regulatory compliance.

Supplier / Subcontractor 

Audits of critical subcontractors & crucial suppliers are vital to your Quality Management System.  

Witness Audit

Qserve offers on-site support during regulatory audits or regulatory inspections.

Mock FDA Inspection

With a FDA mock-inspection we guide you through the inspection process before the FDA visits you.

CE Pre-Audit

With a CE Pre-Audit we guide you through the audit process before the Notified Body appears.

Due Diligence Audit

Considering a merger or acquisition, our due diligence audit is essential to reduce risks.

Clinical Investigation Audit

To verify the execution of the clinical investigation complies to standards and protocols.  

Brazilian GMP Audit

Our Brazilian expert and execute a pre-audit and review your documentation before ANVISA.

Unannounced Audit 

Notified Bodies do an unannounced audit, prepare yourself with Qserve's dedicated program.