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Pre-Approval Inspection and GxP Audits

Helping You Meet Regulatory Compliance Expectations

Any firm associated with regulated activities such as clinical studies, manufacturing of pharmaceutical products or medical devices, production of raw materials, or laboratory services requires routine inspection and GxP audits. Pre-approval inspections are a large part of inspections and your license to operate and commercially manufacture products.

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 and device lifecycle.

Global Expertise Across the Regulatory Spectrum

Our team of specialists includes former FDA inspectors and CQA certified auditors who are proficient in conducting mock inspections, internal audits, vendor and supplier auditing, and gap assessment services. We serve as an extension of an organization’s Quality Department with respect to vendor and supplier auditing or act as a mock regulatory agency representative with respect to preparing your organization for an agency inspection. 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, GLP, GPV, GDPR, Med. Dev., CSV, DI, etc.).

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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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