Who we are
PharmaLex Ireland is situated right on the coast of Ireland. With a team comprising a number of former EU and US FDA Regulatory Inspectors, we work at a strategic and tactical level with our clients, providing holistic advice, guidance and solutions across the entire product lifecycle.
- By being a part of PharmaLex, we have the bandwidth to support the diverse demands our clients are facing.
- We offer immediately accessible support and training to build knowledge and in-house capability, providing them with the tools to make informed decisions and improve operational efficiency.
- By working with our team, our clients benefit from practical solutions and expert guidance relating to their regulatory challenges.
- Our clients tell us that one of the greatest benefits of working with PharmaLex Ireland is that not only do they receive excellent advice, but we also work with their teams to implement our recommendations and, in doing so, their teams gain a wealth of expertise and knowledge.
PharmaLex Brexit Services Q&A with our experts…
- The client was a large multi-national pharmaceutical company for whom PharmaLex provides UK and Ireland regulatory support services.
- The client required PharmaLex to utilise in-house expertise in regulatory, pharmacovigilance and quality management to prepare and guide all BREXIT activities. The client particularly required PharmaLex to plan and lead activities for the CAP conversion process to UK national licences.
- PharmaLex held meetings with the client’s Medical Affairs, regulatory, compliance and lifecycle management leads, to discuss the BREXIT guidance and activities, to fully understand the client’s concerns.PharmaLex created a BREXIT preparedness report summarising key activities for supply chain, regulatory and pharmacovigilance. PharmaLex were able to provide detailed responses to follow up questions.
- PharmaLex created a fully scoped BREXIT plan; to map out regulatory activities, responsibilities and timings. PharmaLex presented the plan to regulatory managers so they could understand the process and ask any questions.
- Based on PharmaLex’s detailed plan the client now has a map of activities; client resource may be allocated and mitigating activities have been put in place. The client is reassured of the processes that are ongoing, in order to ensure regulatory compliance post-transition, and continuity of supply.
PharmaLex took the time to listen to BREXIT concerns and explain the process to a wide internal audience. This allowed for the internal team to focus on their ongoing activities, knowing that BREXIT co-ordination activities actions were being led by PharmaLex.
Key members of our team
Kate has worked in Quality roles in the Pharma Industry up to management level for 16 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines and Oral Dose. Kate is a practicing QP, a qualified Lead Auditor and an SME in Risk Management, New Facility Design/Start Up, QC and Sterility Assurance.
Patrick has worked in various Managerial Quality roles in Global Pharmaceutical Companies with over 25 years of experience, covering several platforms including Biologics, Sterile Lyo & Fill Finish, Vaccines and oral Dose. Patrick is a qualified Lead Auditor and SME in Quality Control, Sterility Assurance, New Facility Design / Upgrade, Risk Management
John has over 20 years’ experience working in a variety of technical and senior leadership roles including Quality Director, Production Director, MS&T projects and specialist roles at both national and international sites. His leadership experience brings strong capabilities in implementing best-in-class strategies in Operational Quality and Quality Systems.
What our clients say about us
We are working with a number of large pharma companies and are looking to create a consortium of partners to collect feedback on expertise, availability and outcomes. If you would be interested in joining our consortium, please contact us on email@example.com.
I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.Lorraine Henry
Compliance Lead, Qualified Person, Amneal Ireland Limited