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Pre-Approval Inspection and GxP Audits

Helping You Meet Regulatory Compliance Expectations

Any firm associated with regulated clinical studies, pharmaceutical products, medical devices, or laboratory services requires pre-approval inspection and GxP audits.

Such companies are expected to be compliant and continuously improving. As your partner, we can maintain alignment with new, existing, and changing regulations and industry standards that evolve throughout the drug product lifecycle.

Global Expertise Across the Regulatory Spectrum

Our specialists are experienced auditors capable of conducting mock inspections, internal audits, vendor, and supplier auditing and gap assessment services. We serve as an extension of an organization’s Quality Department or act as a mock regulatory agency representative. Partnering in a constructive and collaborative manner, we work together to understand, identify, and evaluate systems for quality improvements.

Our large network of compliance consultants covers the globe and has broad knowledge across the regulatory spectrum (GMP, GCP, GxP, GLP, GPV, GDPR, Med. Dev., CSV, DI, etc.).

Contact Us

Looking to Maintain Quality and Compliance for Your Product?

Contact us to learn how our team of specialists can ensure quality and regulatory requirements are met throughout your product’s lifecycle to successfully bring your product to market.

Interested in gaining an industry edge? Let us help you stay current.

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