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
    + 353 (0)1 846 4742
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PharmaLex Series “A day in the life of “

My day starts with a large mug of strong coffee and a read through my emails.  As I work with colleagues and clients round the world, I usually have a lot of emails to catch up on in the morning!

The biggest challenge is also something I love about the job! No two days are the same and my priorities can change several times during a single day so I am constantly juggling several activities.

I love the variety involved in my role and the teams that I work with.  We are a very collaborative team that does whatever needs to be done to achieve our common goals.

If I need to email someone, I open a new email straight away and add their name and the subject.  I then make sure that I finish all of the emails and send them before I close my laptop at the end of the day.

I love holidaying in the UK.  I particularly like the South West (Cornwall and Devon) and Yorkshire.

We had a family holiday in the US (New England) a few years ago and it was our best holiday ever.   I would love to go back and discover other areas of the US.

Yesterday’s shortcuts are today’s nightmares.

PharmaLex Brexit Services Q&A with our experts…

  • My career path spans over 25 years in the Pharma industry working in both Ireland and the UK.
  • Starting out as a QC Analyst at the beginning of my career, fresh out of WIT.
  • I have held various roles across Quality Assurance, Quality Systems, Compliance and Validation working across multiple companies in the fields of API’s, Manufacturing (Commercial and Development across various product forms), Storage, Distribution and Transportation.
  • My roles have led to travels around the world auditing in India, US, Europe, Russia and Singapore.  Most recently my career has focused on quality management and oversight of global and outsourced supply chain and acting as an RP on UK Wholesale Dealers Authorisations.

Senior Manager – Consultant supporting the Pharmalex QMC team and based in the UK

  • Showing my age here, but I learned some valuable lessons over the years. Many of these have been from some great Line Managers who have inspired me to develop and learn.
    • There is always an opportunity for learning and continuous improvement, even in the most challenging situations. Treat challenging situations as an opportunity to reflect and improve.
    • General advice, somethings happen for a reason and it works in our favour.
    • Without a Quality Culture in an organisation, its difficult to implement and maintain compliance, within the Pharma industry Quality has to be at the heart of what we do on a daily basis.
  • Always go with your gut feeling, if it doesn’t feel right its probably not and its okay to question and challenge established processes and ways of working.
  • Helping others to be the best they can be through coaching and guidance.
  • Turning challenging situations around.     Although the current challenges associated with home schooling of a 5 year old may change this!

Confidence beyond compliance.

As the leading provider of specialized services for the pharmaceutical, biotech and medical device industries, compliance is our priority. But it doesn’t stop there.

When you work with us, you can feel confident that your needs have been met, your reputation has been protected, and your business objectives are on track.

Key members of our team

excecutive vp ireland
Patrick Nieuwenhuizen

Consultant / Manager, PharmaLex Ireland

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

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.

Michael Makris

Regional Sales Manager, PharmaLex Ireland

Mike recently joined PharmaLex as Regional Sales Manager (UK & Ireland), with a business development focus on Regulatory Affairs , Pharmacovigilance and Quality.  He joins us with over 25 years sales experience, including over 10 years in pharmaceutical business development, supporting client departments across EMEA, with a focus on drug patent intelligence solutions.

Charley Maxwell
Charley Maxwell

Senior Consultant / Director Quality & Compliance, PharmaLex Ireland

Charley has recently joined Pharmalex as Director QMC and Senior Consultant.  He joins us with 20 years’ experience working in industry in Pharmaceutical and Device manufacturing and importation. His background is B.Sc. In Biochemistry and M.Sc. In Pharmaceutical Manufacturing Technology and he has operated as a QP in Ireland since 2018 for sterile and non-sterile manufacture and third country Importation.

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