FDA Regulatory Quality & Compliance Services

FDA Quality & Compliance

FDA compliance - GCP & GMP auditsWhy is Quality & Compliance Important?

Independent clinical audits for GCP and GMP are part of an intelligent quality system framework and are a vital part of product development.  Current FDA standards require that quality systems ensure safe drug manufacturing and clinical trial oversight; these systems must include established processes for regulatory compliance and risk mitigation.

Often, Warning Letters from the FDA or observations noted during an FDA inspection regarding noncompliance or nonconformance are a result of a dysfunctional quality systemRegardless of the specific situation you are experiencing, you need to respond quickly in order 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.  The Weinberg Group is able to 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 which will have all findings triaged as minor, major, or critical.  All reports are checked by your project manager and by our CEO 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:

To learn more about how The Weinberg Group can help with all of your quality and compliance needs, contact us today.