August 25, 2020
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 clients addresses this growing and strategic part of our consulting business. Mike has over 25 years of financial leadership within
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July 20, 2020
Dublin, Ireland, 20 July 2020 – Orphan Drug Consulting today announced the opening of office space in Boston, Massachusetts, and the further growth of its US-based consultant team with the appointment of Christy Webb as a Quality Assurance consultant. This further expansion into the US market by Orphan Drug Consulting addresses an increased demand for its expert consulting services and follows on from the recent appointment of Tanya Quinn as a Supply Chain consultant in
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June 2, 2020
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 consultant with over 7 years building her own consulting business and over 15 years in industry employed in senior supply
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May 1, 2020
In these uncertain times it can be challenging to comply with regulatory requirements while maintaining supply demands, but there has been advice published by the authorities to help. This guidance has outlined regulatory flexibility that can be applied to help pharmaceutical companies cope with the consequences of the pandemic, while ensuring a high level of quality, safety and efficacy for medicinal products in the EU. As current national and international safety measures and travel restrictions
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April 7, 2020
On 20th March 2020 the EU-GMP Guideline of Annex 21 ‘Importation of Medicinal Products’ was published as a draft. In addition to the guidance outlined in the main chapters and annexes, it was a thought that there was a need to publish a specific guideline on importation of medicinal products under a dedicated annex of the GMP guideline. The annex outlines the principles and guidelines applicable to a manufacturing import authorisation (MIA) holder which imports
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March 18, 2020
On 31st of December 2019, a cluster of pneumonia cases with unknown aetiology were reported in Wuhan, China. At the time, healthcare professionals could not identify the causative agent for these seemingly related incidents but on the 7th of January the Chinese authorities confirmed a novel coronavirus (nCoV) was responsible for the disease. This virus is now known as SARS-CoV-2, and the resulting disease presenting in patients infected with this coronavirus is known as COVID-19.
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