Tony Orme

Tony Orme is an independent pharmaceutical consultant with over 32 years’ experience at MHRA in various areas of the regulation of pharmaceutical distribution. As a former MHRA GDP Inspector with 22 years within the MHRA GDP Inspectorate team where he reached Expert Inspector level, he undertook the most high profile and complex inspections across the UK.

He was the GDP EU Exit Lead and provided the guidance for import, the RPi and supply to Northern Ireland. He led on the implementation of the Falsified Medicines Directive for distributors in the UK and the continued use of the Medicines Verification system in Northern Ireland.

Tony was also involved in the development of most UK GDP policies, including the GDP risk based inspection strategy and supply chain security. He was GDP lead for IAG cases for many years and is ideally placed to help distributors ensure their operations are compliant or help respond to failures and to develop and implement effective remedial actions.

Since becoming an independent pharmaceutical consultant Tony has helped 2 Global Pharma companies secure a UK WDA(H), acted as Responsible Person, carried out audits, training and remediation activities for both commercial and NHS organisations.