RPR Consulting offers two key services to the biopharmaceutical industry:
Regulatory Inspection Preparation and Support
We all recognize that clinical research rarely follows the path that we intend; in the complex world of human clinical trials there are inevitable deviations from plan. Having said that, the time for this to be first discussed is not during a GCP inspection associated with your regulatory submission, and preparedness is key to being able to successfully explain how you correctly dealt with these issues.
RPR Consulting has significant experience in hosting and managing regulatory inspections at both Sponsor sites and Clinical Sites. We can provide a full GCP regulatory inspection readiness program; from initial gap analysis, development of mitigation and remediation strategies, staff training for interviewees and the ‘back room’ team, mock-inspections, through to on-site management and support during the inspection itself.
Quality Management System (QMS) Development
We provide a pragmatic, holistic perspective to improve your existing GCP Quality Management System, or can work with your team to create a tailored, risk-based Quality Management System for your organization from the ground up.
In addition, RPR Consulting provides a thorough review of your procedures to identify opportunities for improvement and deliver “quick wins” for your quality system.