GxP Compliance Consulting

When the production line is someone else’s lifeline, we’re here to help.

With more than 35 years of experience guiding companies through complex GxP guidelines (good practice guidelines), we understand that breaches in compliance can impact everyone, including patients waiting for the treatments they need.

This is why we have over 80 former regulators and inspectors in our regulatory GxP compliance consulting group. These specialists working alongside our seasoned industry experts are here to help you:

• Mitigate GxP compliance risks
• Manage remediations
• Restore confidence 
• Keep patients receiving the treatments they need

We understand not only how to do this, but the importance of reducing downtime, protecting revenue, and maintaining trust with regulatory agencies. 

We have your GxP compliance management details covered, so you can focus on the patients counting on you. 

Services that keep the supply chain flowing:

• Strategic advisory: We help with communications, regulatory submissions and meetings, including preparation or attendance at Health Authority meetings. We’re also there for consent decree remediation and verification activities, as well as Form 483 and Warning Letter responses. We can also provide a loaned executive service when more substantial support is needed.
• Auditing: We assist with general GxP audits, FDA-type mock PAIs and other inspections (including both on-site or virtual), verification audits and effectiveness checks, and gap analyses. We can also consult on good distribution practices, quality systems, and management control.
• Data integrity: We provide directed audits and analysis, subject matter training, procedure development, interviews of staff, internal investigations, and fraud evaluation. Throughout the process, we coordinate our efforts with your legal counsel.
• Inspection support: We provide hosting, front/back room support, mock interviews, readiness assessments, and application conformance reviews. We help you prepare by reviewing hosting processes, site presentations, and tour routes.
• Technical writing: Our writers assist with SOPs, validation protocols and reports, annual product reviews, FDA correspondence, audit responses, strategic plans, and other technical reports.

Learn more about how Parexel’s GxP Compliance Consulting can benefit your organization today.