Barbara is a Registered Pharmacist with extensive industrial experience in the manufacturing environment. She can provide help and support with management of technical and strategic projects together with training in all aspects of cGMP. Experienced in working across cultures including Europe, US and Japan. Key skills and services;

• Project management in clinical trials, operations support or major strategic projects,

• Delivery of training courses,

• Document preparation – validation support and Standard Operating Procedures,

• Regulatory Inspection preparation – support and coaching.

Ian is an Independent Consultant with broad experience of medicinal product development in industry and academia specialising in the safety evaluation of pharmaceutical and biotechnology products. He prepares expert reports, literature reviews, papers for publication, Investigational Medicinal Product Dossiers (IMPD) for Clinical Trial Applications and Common Technical Documents (CTD).

John is a Chartered Statistician. He has worked in all phases of clinical development, the commercial function, R&D and manufacturing. He has been involved in many major international submissions and is experienced in liaising with experts both internal and external to client companies.

Matthew is a Change Manager with a track record of delivering organisational change, focussing on customer needs and service standards. A certified auditor, he has experience in product development, industrialisation, Information Technology, organisation re-engineering and change. Key skills and services;

• Project management for change, operational and strategic projects,

• Quality Management System implementation, operation and continuous improvement (cGMP, ISO 9000, ITIL, Sarbanes-Oxley),

• Regulatory Inspection preparation support,

• Development and delivery of training courses.