Regulatory Services

GxP Auditing

At Quality Resource Solutions, LLC, we understand the importance of continuous compliance monitoring when it comes to GxP (good practice) regulations. That's why we offer GxP Central, a premium auditing service that helps you maintain current and effective compliance efforts.

Our team of experienced consultants possesses extensive domestic and global experience and can cover the entire supply chain, from raw materials to finished products. We specialize in conducting specialized GCP (Good Clinical Practice) audits that focus on the issues associated with Phase I-III facilities.

In addition to our auditing services, we provide training and support for the development of standard operating procedures (SOPs) associated with the current phase of development. We assess compliance with FDA/EU regulations and ICH (International Council for Harmonization) guidelines, ensuring that your organization is meeting all necessary requirements.

Our team also evaluates the databases used to track serious adverse events (SAEs) and investigational new drug (IND) safety reports, reviewing procedures for site visits and associated documents such as monitoring reports and logs. We review the content of SOPs to ensure the procedures and systems used are in compliance with applicable guidelines and regulations.

Furthermore, we evaluate medical laboratories used to support clinical trials, ensuring that they meet all necessary requirements and are in compliance with applicable guidelines and regulations.

At Quality Resource Solutions, LLC, we are committed to providing high-quality GxP auditing services that help you maintain compliance and stay ahead of the competition. Contact us today to learn more about how we can help your organization meet its compliance goals.

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