Pre-Approval Audits

Why is Quality and Compliance Important?

Independent clinical audits for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) compliance are part of an intelligent quality system framework and vital to product development. Current Food and Drug Administration (FDA) standards require that quality systems ensure safe drug manufacturing and clinical trial oversight; these systems must include established regulatory compliance and risk mitigation processes.

Often, warning letters from the FDA or observations noted during an FDA inspection regarding noncompliance or nonconformance are a result of a dysfunctional quality system. Regardless of the specific situation you are experiencing, you need to respond quickly to protect the future of your product and company. We are able and ready to help you overcome these roadblocks that can occur during product development.

How We Can Help

For all issues across the FDA compliance spectrum, it is important to approach the project consistently, accurately, and independently. ProPharma Group can do just this. We take a complete approach, working with you to design, create, and implement the entire quality system.

Although audits are a part of our complete quality system services, we can also work with you on an audit-only basis. Once we understand your needs, we can craft a proposal and statement of work. From here, we work together to develop a project audit plan, schedule your audit, and train the auditor based on your specific needs. When the audit is completed, you will receive an audit report with all findings triaged as minor, major, or critical. All reports are checked by a project manager and by a member of our leadership team for quality control purposes. This plan will be reviewed with you, and we will begin working to fix any issues as soon as possible.

Finally, no matter the location or type of audit, we charge a fixed price per On-Site-Audit-Day (OSAD), allowing you to control the budget.

Our FDA Consulting Services for All Compliance Issues Include:

As our client, you can expect a partner that will be hands-on and work alongside you to provide quality compliance services and the strategy and training to help you improve your quality systems, thus mitigating future risk.

We have consulted with companies of every size, on every continent, supplying them with viable and efficient quality and compliance solutions.

Contact Us

Need Help Navigating the Dynamic Regulatory Market to Bring Your Product Concept to Market?

Complete the form or call us at 2202-833-8077 to discover how 30+ years of regulatory experience using a strategic and scientific approach can deliver successful and expeditious outcomes.

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