Orphan Drug Consulting Appoint Sharon Cullen as Head of Quality
Orphan Drug Consulting is delighted to welcome Sharon Cullen to its growing international consulting team where she takes up the role of Head of Quality. Sharon Cullen is Head of Quality for Orphan Drug Consulting with extensive experience in the Life Science industry, having previously held roles in Quality Management with a focus on the Pharmaceutical […]
Orphan Drug Consulting Celebrates Four Years in Business
Dublin, Ireland, 21 October 2021 – Orphan Drug Consulting Celebrates its Fourth Anniversary. Orphan Drug Consulting is proud to announce the celebration of 4 years in business. Since its establishment in 2017, Orphan Drug Consulting has grown from a core team based in Ireland to a global group with offices in Dublin, London, and Boston […]
World Orphan Drug Congress 2021
Join us at World Orphan Drug Congress 2021 November 15-18, 2021. Orphan Drug Consulting is delighted to be exhibiting at World Orphan Drug Congress 2021 taking place as an event in Barcelona, Spain from 15th – 18th November 2021. Find us at booth 8. Join Jason Cameron at World Orphan Drug Congress as he presents […]
CPhI Worldwide 2021
Join us at CPhI Worldwide 2021 November 9-11, 2021. The in-person event will take place at the Fiera Milano in Milan, Italy. Join us to connect with new partners face-to-face, network, and source innovative pharma solutions on-site from thousands of exhibitors covering the entire pharma supply chain. CPhI Worldwide showcases each stage of the pharmaceutical […]
Orphan Drug Consulting Appoint Jason Cameron as Chief Operating Officer
Dublin, Ireland, 12 August 2021 – Orphan Drug Consulting is delighted to welcome Jason Cameron to its growing international consulting team where he takes up the role of Chief Operating Officer. Jason has over 25 years of experience in the pharmaceutical industry working across supply chain, distribution, manufacturing, and broader technical operations, with a particular […]
EMA Labelling and Packaging Regulations
Introduction The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) in charge of scientific evaluation, regulation, and quality control of medicines in the EU. Before approving medicinal products for distribution in the 27 EU member states along with Norway, Lichtenstein, and Iceland, the EMA makes sure that they meet safety, efficiency, and quality standards. In relation to […]
EU Marketing Authorization Procedures
European Medicines Agency The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralized marketing authorization applications (MAA’s). A marketing authorization (MA) is the authorization of a medicine to be sold in one, several, or all the European Union’s member states, depending on the type of application that has been submitted and to which agency. […]
Webinar: Advanced Therapy Conundrum: Should You Build, Outsource, or Go Hybrid?
Webinar: Advanced Therapy Conundrum: Should You Build, Outsource, Or Go Hybrid? June 22, 2021. 2:00PM EST/ 7.00PM GMT Companies developing advanced therapies have to decide early on: Build capacity, and how much? Outsource, and how little? Mix and Match, and how effective? One thing is certain: You need to clearly understand the opportunities and […]
Acting as a Responsible Person (import) (RPI) in the UK
Background The Medicines and Healthcare products Regulatory Agency (MHRA) recently published guidance called “Acting as a Responsible Person (import) (RPi) from 1 January 2021”. The guidance describes the role of an RPi and how to become a RPi. Also of relevance is the guidance “Sourcing medicines for the Great Britain market from an approved country for […]
Webinar: Launching an RX Product in the EU
Webinar: Launching an RX Product in the EU Fail to Prepare, Prepare to Fail [January 27, 2021. 4:00PM GMT/11:00AM EST] How do you manage a successful pharmaceutical product launch with challenges and variables of 27 EU markets? Our webinar will share some of the following key insights: How key differences between EMA and FDA impact […]