GCP Quality Management

Quality is key to how you conduct your GCP research, whether you are a large or small organization.

The recent addendum to ICH-GCP Guidelines for Good Clinical Practice E6 (R2), effective 14 June 2017, and the ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6 is a clear indication that regulators worldwide agree that a robust Quality Management System is an integral part of your approach to Research & Development to ensure patient safety and robust scientific methodology.

More Sponsors are finding their existing Quality Management Systems under the spotlight as regulators now include an in-depth assessment of quality practices during their Regulatory Inspections. Proving the suitability of the Quality Management System can be an issue for many organizations of all sizes.

RPR Consulting provides GCP Quality Management consultancy to pharmaceutical and biotechnology organizations of all sizes.

What We Do

RPR Consulting offers a pragmatic, holistic perspective to improve your existing GCP Quality Management System, or 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.

Contact

For more information on how RPR Consulting can help you deliver your GCP Quality Management System

Phone: (+1) 484-983-4583

Email: rprconsultinginc@gmail.com

About

Richard Reeve, President of RPR Consulting, has over 25 years experience in Clinical Quality Management and Clinical Operations in Pharma, Biotech and CROs in the EU and US and a proven track record of establishing and re-engineering GCP quality systems.

Combining a business-focused approach with practical operational experience he quickly identifies potential compliance issues and areas for optimization in your GCP system.