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.
Jane Lyons Q & A
I am lucky my children are older so I don’t have the added pressure of home schooling. I’m at my desk at 7.30am to get ahead of the day. There are a lot more virtual meetings throughout the day so early morning and evening are critical times for actionable items. And how do you engage with your colleagues? From the outset we set up daily calls to ‘check-in’ with the team and discuss action items for the day. We also introduced ‘virtual coffee-breaks’ twice a week and weekly morning meditation so that we stay connected.
Our first thought and priority was ‘how can we help? What can we do to assist industry at this time?’ So we set up our #AskTheExpert service so clients can engage with one of our consultants on COVID-related technical queries. We then contacted industry representative bodies to offer support to their members. We have taken part in a virtual audit Q&A session with BioPharmaChem Ireland, we are conducting a Virtual Audit webinar with PDA Ireland to share our insights with companies as to how to manage their internal/vendor management audit programmes during and post-COVID. We are hosting a COVID-related Supply Chain webinar with Nibrt in June and in August we are hosting a webinar for ISPE India on Virtual Audits.
For some of our services such as QMS development, it is business as usual. For other typical ‘on-site’ support we looked at how we could adapt our service offering to fit the current circumstances. Whereas we typically provide on-site training solutions, we quickly moved to a virtual setting to enable our clients to continue to deliver their annual training programs to their teams. We also adapted our auditing and PAI services to a virtual model so that clients can continue to meet their compliance requirements and prepare effectively for expected post-COVID regulatory inspections. We are assisting clients with their risk assessments of their supply chains where new suppliers have been on-boarded and new routes require assessment.
It is so dynamic – each day there is a new opinion/discovery relating to a potential vaccine. I have family working in the front line so am extremely grateful to see industry coming together to collaborate to fight COVID-19. It is heartening to see scientists working together to create a safer world for all.
I read a poem about the pandemic by Damian Barr which suggests that while we are all in the same storm, we are not all in the same boat. So for me lessons learned include: 1) That those fortunate enough to have an easier ride have a responsibility to care for those who are suffering most. I hope this message continues to resonate within society post-COVID and 2) that we always remember this time when nature truly reminded us that we are all visitors on this planet and as such it is our duty to respect it.
Key members of our team
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.
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.
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 email@example.com.
We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.Med Device company, US
Senior Regulatory Affairs Director
We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.Small Medium Sized Company, UK
Head of Regulatory Affairs
Able to explain technical details so non-experts can understandUS based small / virtual company
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