Acting as a Responsible Person (import) (RPI) in the UK

EU Marketing Authorization Procedures

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 […]

BREXIT: Approved Country Lists Post-Transition Period

EU Marketing Authorization Procedures

Countdown to Transition Period End Date Days Hours Minutes Seconds Introduction On 31 December 2020, the Brexit transition period will officially end which means that from 1 January 2021 changes to the current arrangements in place may occur. During the transitional period, the UK has remained a member of the European Economic Area (EEA), the […]

Orphan Drug Consulting Appoint Grainne Higgins as Human Resources Consultant

Grainne Higgins Orphan Drug Consulting

Dublin, Ireland, 28 September 2020 – Orphan Drug Consulting is delighted to welcome Grainne Higgins to its growing international consulting team. Grainne’s focus will be twofold within Orphan Drug Consulting, both supporting our clients with their Human Resources needs across talent/recruitment/organizational strategy & development; in addition to providing Executive and Leadership coaching to implement best […]

Orphan Drug Consulting Appoint Mike Gannon as Financial and Entity Planning Consultant

Mike Gannon Orphan Drug Consulting Financial and Entity Planning

Dublin, Ireland, 25 August 2020 – Orphan Drug Consulting is delighted to welcome Mike Gannon to its growing international consulting team. Mike specializes in helping organizations grow and develop internationally as well as advising on optimum structures for finance, tax, treasury and business administration and support functions. Providing this expert advice to Orphan Drug Consulting […]

Orphan Drug Consulting Appoint Tanya Quinn as US-based Consultant

Dublin, Ireland, 02 June 2020 – Orphan Drug Consulting is delighted to welcome Tanya Quinn (through her company Knowledge Base LLC) to its international consulting team. Tanya will support Orphan Drug Consulting with its growing client requirements in the US from her New York/New Jersey-Metro location. Tanya is a well-respected, experienced senior supply chain management […]

Pharmaceutical Business Continuity Plan as a Key Component of COVID-19 Pandemic Response

  “To be a proper business continuity plan, a company needs to roll it out across its entire organization, there needs to be clear roles and responsibilities for people and the plan needs to be simulated and practiced.” In response the COVID-19 pandemic, this webinar examines business continuity planning as a risk mitigation strategy. David […]