Quality Management and Compliance
Insights Hub
Our Quality Management and Compliance (QMC) team is involved in all aspects of the Product Lifecycle from innovation to commercialisation providing strategic consultancy related to compliance in every stage from development to product withdrawal. From early innovation, we guide our clients through all stage gates towards and beyond commercialization, consulting with them on anything that will impact the quality and compliance of the final product
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Blog & Article
- 14th November 2024
What are the biggest challenges in achieving and maintaining sterility assurance in pharmaceutical manufacturing? The first thing to realise is that sterility of a…
Blog & Article
- 12th November 2024
The Windsor Framework sets out the arrangements for the supply of medicinal products into Northern Ireland and comes into effect 1 January 2025. Through…
Podcast
- 13m
Pharmaceutical companies new to the EU market must navigate complex and varying commercialization requirements. The podcast highlights key steps for commercialization readiness in Europe,…
Blog & Article
- 30th October 2024
The PDA Ireland Chapter hosted an event to discuss how innovation and technology are embraced in the industry of Biopharmaceutical manufacturing. The event took…
Blog & Article
- 30th October 2024
The concept design review is a critical step and a foundation in designing a manufacturing facility. The review provides the opportunity to see the…
Blog & Article
- 10th October 2024
The Annex 1 revision has been in force since August 2023 and manufacturers are expected to be compliant with the guidance[1]. Yet there remains…
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