Keith founded GXPi in 1999 and brings over 20 years of Life Sciences experience, particularly in a pragmatic approach to computer systems validation.  Having been involved with and seen the benefits of correctly implementing compliant software tools within large pharmaceutical organisations he identified the gap with more cost effective solutions for the market. Keith initiated the concepts that have led to the current family of products in 2007 and he remains activity involved with the product development programme as well as sales and marketing activities. He has worked in a manufacturing, laboratory and clinical environment extensively in Europe and the US. He has a BSc in Genetics and Microbiology and an MSc in Biochemical Engineering.

Mark joined GXPi in 1999 and became a director and investor in 2002. In 2004 he became responsible for the running of the consulting business and drove the successful restructuring of that operation into the model that exists today. He has 20 years of experience with managing teams and delivering projects that have utilised a risk based approach to achieving compliance within EU and US markets in a cost efficient manner. Mark has been responsible for building a team that is able to provide rapid response in managing critical compliance issues and help customers resume commercial operations in the shortest possible time. Mark has BEng in Chemical Engineering with Biochemical Engineering.

Peter is GXPi’s representative in North America. He has worked for over 28 years in the biopharmaceutical industry in positions of increasing responsibility in both Europe and the US, culminating in being responsible in the last eight years for all Technical Operations in two different biopharmaceutical Companies. Dr. Clarke, who carried out research for his Ph.D. at the Imperial College in London, has led teams that have developed biopharmaceutical manufacturing processes and their associated analytical methods. He has been the technical lead in facility design, commissioning, validation and start-up and has been responsible for the technical content of CMC sections of eCTD’s successfully submitted to the FDA and EMA. As part of the licensure of five disparate biological products Dr. Clarke has interacted directly with Regulatory Agencies including FDA (CBER and CDER), EMA, BfArM and AIFA.

Phil is a chemist by background, now a specialist in Quality Management Systems and in the validation and compliance of Information Systems used in the Pharmaceutical Industry. He has more than 20 years’ experience in large organisations operating in a GxP environment, covering Research & Development and Active Ingredient manufacturing. In a consultancy role, Phil has helped clients to implement pragmatic and practical solutions to a wide range of GxP compliance and validation issues. He also manages GXPi’s own QMS covering software development in line with GAMP® 5 recommendations.

Jon is an Electronic Engineering graduate with over 10 years technical and management experience working with Information Technology and Software Development projects. He has an MCTS in SharePoint Configuration and manages the product output from the software development team and the technical delivery teams. He has a broad technical knowledge particularly around infrastructure, virtualisation, automated scripting and hosting environments and has worked on projects in Europe and the US.