GxP Consulting Extends Portfolio with Regulatory Compliance Project Management Service to Streamline Project Delivery in Drug Development and Manufacturing

GxP Consulting, a leading provider of compliance services to the pharmaceutical and biopharmaceutical industries, today introduces an extended regulatory compliance and validation project management service to its portfolio of expertise. The extended portfolio of service means that GxP Consulting can ensure companies have the necessary skills, training and support needed to deliver projects efficiently and effectively - whilst complying with the regulatory requirements of the MHRA, FDA, EMEA and ICH.

Led by Tom Dine, the new regulatory compliance and validation project management team at GxP Consulting provides a service that integrates and understands the requirements of the entire drug development lifecycle; from pre-clinical studies through to the manufacture and distribution of approved drug products. The GxP Consulting team has experience of successfully delivering projects to its clients worldwide for the approval and distribution of drug products in a variety of regulatory markets. Expertise within GxP Consulting covers all areas of Good Practice compliance, incorporating Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).

Mark Stevens, managing director of GxP Consulting, said: “Tom has been involved with regulatory compliance, validation, Quality Assurance (QA), project management, product development and Quality Control (QC) analysis method development of pharmaceutical, biopharmaceutical and cosmetic manufacturing operations for 25 years. He has worked with many of the world’s leading pharmaceutical and biopharmaceutical manufacturers. Tom has worked across a broad range of business areas incorporating research, development, pilot plant and commercial manufacturing facilities. His experience means that he is able to lead our regulatory compliance and validation consulting team and help deliver valuable support to our clients”.

GxP Consulting, a growing business, has increased its regulatory compliance project management service in response to customer demands. With recruitment restrictions, budget cuts and an increasing need to provide essential regulatory compliance expertise and management as cost-effectively as possible, GxP Consulting has been able to provide high-value, tailored solutions for its clients. By providing interim management, ongoing part-time support and project-specific support, GxP Consulting is able to offer its clients a range of smart options to suit all business requirements and budgets.

Tom Dine, Regulatory Compliance and Project Management Principal Consultant, said: “We are uniquely positioned to be able to provide our clients with knowledge and experience that combines the discipline of project management with a comprehensive technical and regulatory compliance understanding of the development, approval, manufacture, packaging, storage and distribution of pharmaceutical, biopharmaceutical, medical device, veterinary and homeopathic products.”

Headquartered in Nottingham, UK with offices in Irvine California, GxP consulting provides high-value, results-focused regulatory compliance services to the highly regulated pharmaceutical and biopharmaceutical industries. The company has expanded in order to support its growing number of clients with ever increasing requirements of regulatory compliance, covering pre-clinical (GLP), clinical (GCP), manufacturing (GMP) and wholesale storage & distribution - Good Distribution Practice (GDP) business areas.

The GxP Consulting team is able to support the planning, management and implementation of validation regardless of the scale of the project. The team is able to help with activities such as preparation of the Validation Master Plan (VMP), Cleaning Validation strategy, Process Validation (PV) strategy, Clinical Study Project Management and Validation Project Management – as well as Quality Assurance (QA) support.