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
    Senior Manager, Client Services PharmaLex Ireland Suite 2, Stafford House
    Strand Road, Portmarnock
    County Dublin D13 H525
    Ireland
    + 353 (0)1 846 4742 ireland@pharmalex.com

Key members of our team

Colette Dolan

Director, Head of Quality & Compliance, PharmaLex Ireland

Colette has over 30 years’ experience in the pharmaceutical manufacturing sector including senior leadership roles in Quality, Operations and Supply Chain. This breadth of experience enables Colette to bring a holistic understanding of technical requirements with consideration of recommendations across all areas of manufacturing and supply chain operations.

Kate Coleman

Senior Consultant/Manager Quality and 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.

Ann McGee
Ann McGee

CEO, PharmaLex Ireland

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.

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.

  • 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
    President
  • 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
  • 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
  • We couldn’t have asked for a more professional, personable, knowledgeable group of Quality Experts!

    Top 10 Pharma Company, China
    Drug Safety Director