“To support our Wholesale Distributors Authorisation license application, we engaged the services of PharmaLex Ireland to design, develop and implement a Quality Management System. With a demanding timeline, we required a consultancy with an excellent depth and breadth of knowledge to be capable of meeting the required deadline. For us, PharmaLex Ireland was a natural choice.
Anonymous from one of the top ten generics companies
Gilead Sciences Inc. has engaged the services of PharmaLex Ireland to provide support across a wide range of Quality and Compliance projects, such as supply chain risk assessments and EU inspection readiness audits, in accordance with US and EU regulatory requirements.
PharmaLex Ireland has consistently provided invaluable support and advice enabling our teams to achieve and exceed their quality and compliance requirements. The team’s in-depth understanding of the interdependence between functions and GxPs has enabled us to proactively resolve future problems before occurring. Coupled with a team that includes former EU Regulators ensuring that the regulatory perspective is factored into advice, Gilead Sciences Inc. can maintain focus on its core activities.
Finally, PharmaLex Ireland’s level of customer service and personal attention is phenomenal. The consulting experience is collaborative, engaging and thoughtful. I would highly recommend PharmaLex Ireland for quality, technical, regulatory or compliance services.
Robbi Wyatt, Senior Director QA, Gilead Life Sciences Inc.
When looking for a consultancy with experience in GMP compliance, I immediately thought of PharmaLex Ireland. As a former senior regulator with the Irish Medicines Board [now the Health Products Regulatory Authority] I was confident in PharmaLex Ireland’s ability to provide an in-depth professional service while working with the team in Pfizer Biotech to ensure their understanding of the practical implications relating to GMP compliance.
PharmaLex Ireland worked on a number of projects with us, such as providing QP training, and I would have no hesitation in recommending the services of PharmaLex Ireland.
Senior Director, Quality, Pfizer
Sanofi Pasteur MSD has used the services of PharmaLex Ireland to perform audits and gap analyses on our business processes and supporting Quality Systems and procedures to support an expansion of our business activities. PharmaLex Ireland worked with us to develop and revise processes, systems and procedures to fill the gaps identified. PharmaLex Ireland also prepared us for an Irish Medicines Board [now the Health Products Regulatory Authority] audit and thanks to them, the outcome of that audit was extremely positive. PharmaLex Ireland has been enormously helpful to us in defining the areas of greatest risk to our business relating to regulatory compliance and GDP and ensuring that those risks are appropriately and adequately controlled. The PharmaLex Ireland team have worked closely with us in SPMSD to make sure that our processes are in line with best GDP practice. You may wonder if you can afford PharmaLex Ireland, but the more important question in mind would be, can you afford not to!” For SPMSD the outcome was well worth the investment.
Country Manager, Sanofi Pasteur MSD
PharmaLex Ireland was engaged by Allergan Limited, UK to review the design and implementation of key systems and processes to evaluate MAH compliance and ‘inspection readiness’ in the areas of Healthcare Compliance (HCC), Medical Information and Regulatory Affairs. This project also included facilitation of risk assessments to support the company to develop a quality improvement action plan and performing mock inspection interviews with SMEs (subject matter experts) as part of the inspection readiness programme.
I found the consultants extremely professional throughout the project and their in-depth knowledge of regulatory requirements ensured their recommendations were insightful and pragmatic. I would highly recommend the services of PharmaLex Ireland.
Senior Director, EU Regulatory Operations, Allergan Ltd
Our company engaged the services of PharmaLex Ireland as part of a quality improvement programme of one of our Irish facilities. Ann and her team of consultants provided quality and regulatory compliance support to ensure compliance with the requirements of EU and FDA current Good Manufacturing Practice (cGMP).
The work carried out by the PharmaLex Ireland team of consultants over the last 18 months has been impactful and has made a very positive difference to this facility’s operations. I would highly recommend the services of PharmaLex Ireland for the provision of quality and regulatory compliance consultancy. I have found PharmaLex Ireland to be extremely professional and approachable throughout our interactions and wish them every success in the future.
Vice President EMEA Quality, Multinational Pharmaceutical Company
Allergan Pharmaceuticals Ireland EuroCentre worked with PharmaLex Ireland to help to identify opportunities for improvement of our Quality Management System governing our European based GDP operations and to redesign some elements of the QMS to achieve the improvements that we wanted. The PharmaLex Ireland team provided a high level of expertise in a very professional, effective and efficient manner, providing us with solutions that are tailored to suit the needs of our business. We would highly recommend PharmaLex Ireland for this kind of work.
QA Manager, Allergan Pharmaceuticals Ireland, Eurocentre
I confirm that PharmaLex Ireland supported Genzyme Europe in finding a path forward in improving the connection between the MAH and the European manufacturing sites and QP’s during a couple of workshops with a variety of disciplines involved. With PharmaLex Ireland team’s knowledge and experience they align views and consequently brings about the climate and energy to shape the project. Genzyme Europe has certainly gained in knowledge about the various regulatory MAH requirements and authority inspection’s expectations and is now in a much better position to define the necessary projects and goals to improve the MAH-manufacturing structure.
Senior Director, Quality Systems & MAH Compliance, EMEA, Genzyme Europe
PharmaLex Ireland provided a first rate service to us when reviewing our current pharmacovigilance systems. Scoping out the work in advance was very helpful and ensured all aspects were fully addressed. The Review was very thorough and the time taken to explain regulatory expectations/requirements to personnel really helped to reinforce their understanding of same. The work carried out by PharmaLex Ireland has given the site an excellent platform upon which to improve our current systems. It was a pleasure working with PharmaLex Ireland and I look forward to working with PharmaLex Ireland on future site projects.
RA Manager, Genzyme Ireland Limited
We used PharmaLex Ireland to lead an audit team in the conduct of GMP compliance audits at one of our European and at one of our US sites relating to the manufacture of API and sterile finished products. The audits were extremely comprehensive and thorough in their scope and content. PharmaLex Ireland was very professional in their dealings with all stakeholders and while the experience was challenging for the sites concerned, PharmaLex Ireland managed to engage the enthusiasm and commitment of staff through open, communicative style. The PharmaLex Ireland team are a very competent auditor, with knowledge across a broad range of disciples and topics. The audits have been enormously helpful to us in designing and implementing our continuous quality improvement programme.
Head of Quality, Mallinckrodt Medical BV, The Netherlands
As a start-up Indian CRO we were looking for someone who could play the role of a friend, philosopher and guide and help to gear up our practices, systems and approach to be in line with International requirements of Good Laboratory Practices and Good Clinical Practices. Inspection carried out by PharmaLex Ireland was very much useful and beneficial from this perspective. It helped us not only identify the gaps between our desire and reality but the discussions with them helped appreciate and understand the issues from a fundamental perspective. Since the visit we succeeded in putting in place many of their suggestions and ideas and in the process emerged to become a GLOBAL STANDARD CRO
Director, CRBio, India
PharmaLex Ireland carried out GCP and GMP audits on key third party companies based in India on behalf of Eirgen Pharma. PharmaLex Ireland’s audits were exceptionally thorough and wide ranging and have provided us with a detailed framework and set of recommendations which will form the basis of our management of these relationships into the future. In addition, her findings will form the basis of our pre-requisites for third parties on an on-going basis. I would highly recommend the services of PharmaLex Ireland.
Technical Director, EirGen Pharma Ltd.
“PharmaLex Ireland helped Biostór to design and develop a Quality System to support its advanced biorepository service for tissues and cells. The PharmaLex Ireland team provided a very professional and competent service in a timely manner and their advice was always directly relevant and pertinent to the nature of our business. Their support contributed directly to our very successful regulatory inspection.”
Technical Director, Biostór
RCSI appointed PharmaLex Ireland to carry out performance assessments in the area of Professional Competence Assurance in Pharmacy Practices. We found their in-depth knowledge of legislation and best practice standards on this topic to be exemplary. Their professionalism and commitment is outstanding and I would have no hesitation in using the services of PharmaLex Ireland again.
Head of the School of Pharmacy, Royal College of Surgeons in Ireland
“When looking for a solution to ensure Best Practice for Janssen globally, I immediately thought of PharmaLex Ireland. Having worked with Ann on previous projects in Janssen in Ireland, I was confident that with Ann’s previous experience as a regulator nationally and her involvement in influencing the development of best practice for the pharmaceutical industry at a European level, PharmaLex Ireland would be the best provider for our QP training requirements.
PharmaLex Ireland designed and delivered a customised 3 part training course on Roles and Responsibilities of the QP for Janssen which was delivered by a combination of e-Learning and a face-2-face workshop to Janssen personnel worldwide. The course was tailored to the specific needs of our team of QPs at Janssen. What particularly impressed us was that the e training provided a unique opportunity for our personnel to engage in live, online, interactive training in real time. Over 50 associates in different time zones around the world participated in this training. Our core objective was to ensure that QPs of Janssen and other quality associates in the global supply chain had a common understanding and best practice approach on European requirements. Ann and her team certainly delivered on our requirements in an extremely professional manner.”
Senior Director Quality Operations, Janssen Pharmaceuticals Ltd