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

  • Jane Lyons
    Country Manager, Ireland PharmaLex Ireland Suite 2, Stafford House
    Strand Road, Portmarnock
    County Dublin D13 H525
    Ireland
    + 353 (0)1 846 4742

Ann-Marie Purcell Q & A

  • At first it was a challenging adjustment both working from home full time and getting your head around the pandamic and the implications for our families and the community in general.  However I have really settled into working form home and find it so conducive to a good work life balance.  We have a “rule” that we put video on whenever we have a call or catch up, and that keep the engagement real with both colleagues and clients.
  • As a company we have responded exceptionally well to the crisis.  Within a few hours of the announcement here in Ireland we were all ready to work from home.  We have daily meetings and the company has introduced some great initiatives such as mediation, yoga, coffee breaks and the occasional cocktail hour (after work of course!) which really helps the team spirit and replaces those “water cooler” chats.
  • We have been very active in the industry supporting our clients, specifically our ask the expert campaign and our newsletter have been a great source of help to companies.  We have also done a huge amount of work on Virtual audits to help our clients embrace this new way of working.  Specifically there are some great articles and webinars which have been very useful . Read More
  • I think working from home has become the new norm – which could be a positive we take out of this.  Its good for work life balance and for the environment as there is less traffic on the road and less stress on public transport.  I think most companies are seeing that productivity has increased so it’s a win win situation.

Key members of our team

diretor quality and compliance
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.

senio consultanct director quality and compliance
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.

excecutive vp ireland
Patrick Nieuwenhuizen

Consultant/Manager

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

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.

  • 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