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.
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.
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.
Ann has over 30 years work experience within the pharmaceutical industry, as both a regulator and a consultant. Her experience spans quality and regulatory compliance (GxP) across the product lifecycle. Ann has inspected nationally and internationally on behalf of the EMEA for GxP compliance and has advised on best practice guidance for the pharmaceutical industry.
John Cahill Q & A
There are many aspects of the healthcare industry that are exciting at present. The traditional boundaries of different disciplines in medicine discovery and manufacture appear to no longer exist. For example, in the manufacture of medicines, we no longer have just pharmaceutical drug products that are prepared on a massive scale and shipped all over the world for mass consumption. The newer treatments that replace and supplement traditional medicinal drug product provision include individual and combinations of treatments which incorporate biotechnology, cell and gene therapy and medtech technologies. These technologies have revolutionised medicine at a pace that manufacturers, distributors and regulators have found difficult to keep up with.
Healthcare data and its analysis has also become a holy grail for medicine discovery and development. As Stanford University School of Medicine has published “The sheer volume of health care data is growing at an astronomical rate: 153 exabytes (one exabyte = one billion gigabytes) were produced in 2013 and an estimated 2,314 exabytes will be produced in 2020, translating to an overall rate of increase of at least 48% annually.” This huge volume of data is being adopted and analysed by global research programmes using artificial intelligence for cutting edge developments in areas such as robotics, health diagnostics and tracking.
The potential for improving the quality of patient’s lives using new technology and data is what excites me most…it would seem that the future of medicine provision is complex but very bright.
There are many challenges facing the healthcare industry at present and more on the horizon. Brexit, the globalisation of supply chains, decreasing healthcare budgets and technology complexity are some of the well-publicised challenges that currently exist. Over the longer term, climate change will play an influential role in our industry’s development. Pressures for more environmentally sustainable products and supply chains will be brought to bear. The timeliness, logistics and costs of treating patients with severe diseases using some of our new technologies will continue to challenge the industry into the decades to come.
As reported in the news at present, the opening salvos are being communicated between the UK government and the EU regarding the future of trade between the two jurisdictions. It is impossible to predict how this will be play out over the next 10 months but one thing that appears clear is that there is no desire by the UK healthcare industry to deviate significantly from EU rules and regulations such that mutual recognition of each other’s MAH responsibilities, inspections, QC testing and batch release processes will not be possible after the 2020 transition period. Whether this desire is translated into UK government policy is highly questionable, and whether there is any distinct advantage for the UK to deviate from EU regulations on the manufacture and supply of medicinal products remains to be seen. It will be very interesting to see what approach the MHRA ultimately recommends during the implementation of the EU GMP Annex 1 revision later this year.
I believe all organisations should exhaustively strive for effective and efficient systems of work, none more so than an organisation’s Quality Management System which ultimately should reduce risks to product quality and patient safety. I also believe that organisations should use all of its internal resources to resolve complex issues and manage challenging events that arise in medicinal product marketing, manufacture and distribution.
However, what I have come to appreciate and highly respect is that
- Myopia, complacency and fatigue are natural human modalities and it is frequently the case that when you work with a system closely over extended periods of time, a fresh pair of eyes can lead, inspire and contribute to sustainable improvements with an ROI.
- Sometimes to take a big step forward in a particular area that requires change and improvement, outside support is necessary to provide the ‘shot in the arm’ to succeed in making effective change.
- Some problems may appear unique to one organisation but commonplace across an industry.
- A global outlook and understanding is required for challenges that go beyond international borders
- There is frequently connectivity between client challenges that span areas such as Quality and Compliance, Regulatory Affairs, Pharmacovigilance and drug development.
In each of the areas (a) to (e) above, PharmaLex play a significant role in providing broad-spectrum and targeted support to their clients. At PharmaLex we are fortunate to get a first-hand comprehensive view of the issues that face multiple clients. PharmaLex’s breadth of services with international expertise in each of our service areas are uniquely placed to provide our clients with the solutions and momentum they require.
Having obtained my PhD in Chemistry and worked in the early part of my career in API development and manufacture, I have a strong background in drug scale-up and technology transfer. Moving into drug product manufacture of oral solid dosage products, veterinary products and topical formulations provided me with a full appreciation of the technical complexity and supporting systems that these operations require. Experience in managing sterile fill finish facilities, becoming QP qualified and being a site Quality lead, in addition to being part of a site senior leadership team, were pivotal in my professional development. Furthermore, working in both France and Denmark has assisted me in understanding different cultures and approaches in the pharmaceutical industry.
Joining PharmaLex in 2018 has been very exciting, fast paced and a learning ladder (not a curve!). I train, audit, advise, risk assess and troubleshoot for clients in all areas of the drug product lifecycle. One of the main elements of my role is to obtain a detailed understanding of a prospective client’s requirements and ensure the right expertise is identified that delivers exactly what is expected. In over 20 years, I have learned where and how solutions can be obtained in the pharmaceutical sector and it is highly motivating to utilise this experience for such a wide variety of clients. It is a privilege to be part of an organisation that has an excellent track record in client satisfaction.
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 firstname.lastname@example.org.
PharmaLex is dedicated to delivering a comprehensive portfolio while their modular approach allows tailor-made solutions. They acknowledge our feedback, modify their approach and adapt accordingly.Top 10 Pharma Company
Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.US Biotech
Senior QA Associate
What was especially important to me was their ability to get a team, with the right experience, together so quickly.Mid-size Biotech
Head of Outsourcing
We needed to develop our strategy and PharmaLex had exactly the experience we needed.Med Device company, UK
Senior QA Director