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

Charley Maxwell Q & A

  • Moving from a formal office environment to remote working was actually not entirely as tricky as I first expected.  I was very lucky, in joining Pharmalex I was coming in to an environment where remote working and the associated agility this brings to the business was already well established.  As a frequent traveller in some of my previous roles I had often worked occasional days from home in the past and therefore it wasn’t that much of a culture shock to me.  Onboarding and working remotely straight away however I have had to really try to be clear on who is doing what so I don’t end up overlapping activities and also to fight the temptation to overcommunicate.
  • I like to treat remote working as close to going out to work as possible by sticking to an established morning routine and stepping out for 5 minutes to clear my head before sitting down at the laptop and making sure I get my coffee’s and lunch breaks appropriately throughout the day.  I feel that this allows me to keep focussed and productive and not overstretched or distracted by home life.
  • Pharmalex have been incredibly agile and were able to pivot immediately to  adapt to the changing needs of our clients.  Most notable is the provision of virtual audits, remote training and providing support to clients who have experienced significant upheaval as a result of Covid19.  We are looking closely at the changing regulations not only around Covid19 but also Brexit and MDR/IVDR, and checking in with our clients to make sure that they have the required support that they need and if we can help in any way.
  • The reality is that business must go on, and companies that planned to launch new products or obtain new licences prior to the Covid19 pandemic still need those projects to proceed regardless of the hierarchy changes or pressures within their organisation.  We are here, ready to support and would be delighted to talk to new clients who maybe haven used our services but who need a consultants support to get back on track.
  • At Pharmalex  there is a very practical common sense approach to remote working with established two-way communications across the teams.  We video chat on Microsoft Teams directly through the week, in daily catch-ups and huddles which allows us to keep up to date as if we are in the office.  We even have meditation, virtual yoga and virtual coffee breaks where we can share a brew and catch up on the office banter!   This really helps to keep us all motivated and supported while working from home.  I’m incredibly lucky as there is a very supportive team structure already in place and everyone has been really kind and patient with each other.The nature of our work requires daily collaboration across the team, so even though we are all remote working, everyone is actively engaging with each other behind the scenes.
  • I am finding increasingly that instant messaging on Teams is the ‘go to’ in place of the stroll over to a colleague’s desk or just waiting to chat to them over lunch.  I will shoot off an IM either for a quick question or to ask “are you free for a quick chat”.  That way if they are stressed, in the zone with a technical piece of work or on a call you are giving them the chance to let you know that they’ll come back to you when they are free.

I have been greatly impressed by the way that the supermarket and food companies such as Supervalu and our local garages and convenience stores have adapted to the Covid19 pandemic.  The immediate availability of home delivery and the way that sanitation and distancing measures were very quickly implemented such as Perspex divisions for the staff, one way systems to minimise pinch points and priority hours for key workers and the elderly.

Also a lot of medium and larger Irish retailers like Eason’s strengthened their online presence and made it easier and more straightforward to do things like click and collect or buy online and collect instore.

Key members of our team

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

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.

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.

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