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.

Local Contact

  • Victor Cowper
    Director, Business and Client Development, QMC PharmaLex Ireland Suite 2, Stafford House
    Strand Road, Portmarnock
    County Dublin D13 H525
    + 353 (0)1 846 4742

Key members of our team

Ann McGee
Ann McGee

Global Partner QMC

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

Director, Senior Consultant, Quality and Compliance, PharmaLex Ireland

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.

Kate Coleman

Senior Consultant / Director Quality & Compliance, PharmaLex Ireland

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.

Q&A with Kate Coleman

Q & A with Kate Coleman

I was interested in joining PharmaLex as I had worked with them when I was in industry and knew that their priority was providing robust solutions to some of the common challenges currently facing the Pharmaceutical Industry. PharmaLex brought a practical hands-on approach to issues and challenges and gave our team a different perspective.  Joining Pharmlex gave me the opportunity to really use my experience while still providing me with many learning opportunities to expand that experience. I love the variety in my role and working with many different people in the industry.

My undergraduate degree was in Industrial Microbiology and my Microbiology knowledge and experience underpins everything I do. This foundation has been invaluable when working with clients involved in Steriles, Biologics, Vaccines and ATMPs. I also have an MSc in Pharmaceutical Quality Assurance which expanded my Pharmaceutical education and allowed me to branch out from Microbiology into other areas of Pharmaceutical Quality. This MSc included a Thesis on Quality Risk Management which is now an area of expertise for me and something I am known to be passionate about!.  I also have a Post Graduate Diploma in Manufacturing Technology which allows me to be recognised as a Qualified Person in the EU and I have enjoyed my time as a practicing QP.

The landscape is changing in the Pharmaceutical industry as we start embracing novel technologies and I’m fascinated by personalised medicine and the impact these types of novel technologies will have on many traditional areas such as QC, QA, Sterility Assurance, Risk Management and QP disposition.. The direction the industry is taking will challenge all of us to move out of our comfort zones and that sort of challenge is always exciting. Also, the continued focus on Quality Risk Management continues to highlight the interdependencies between all the processes and systems in a pharmaceutical facility and working in this more holistic environment is very exciting when compared to the historical approach to Quality which was more siloed and removed from the heart of the pharmaceutical process.

With any change comes uncertainty and the biggest challenge I see in the industry is overcomplication of processes and procedures and a move away from effective simplicity. I often see very complicated processes and procedures that have become far removed from the basic principles of Quality or Risk. The challenge for the industry over the next number of years will be to peel away the complexity in areas where it isn’t required and become comfortable again with processes and procedures that are scientifically sound but easy to implement, follow and maintain. Unnecessary complexity becomes a burden and can be very difficult to manage long term.

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 contact@pharmalex.com.

  • 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
  • During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.

    Large Pharma, Germany
    VP Regulatory Affairs
  • Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

    Leading European Specialist Pharma Company
    Head of Medical Writing and Publications
  • 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