Since November 2013 Dr Jenny Walsh has provided an outstanding regulatory consultant service for us. Jenny worked on the LENA project for us, a pan-European project funded under the Framework 7 of the European Commission. Jenny is very keen in all aspects of both pharmaceutical development and regulatory affairs. Her profound knowledge on paediatric drug development was very useful for our company.
She has prepared or supervised all required regulatory documents including investigational medicinal product dossiers and paediatric investigation plans. Jenny always delivers high quality work and in time. Her quality of written and verbal communication is extremely high which was beneficial for the cooperation within the consortium and the communication with the EMA. It has been a pleasure to work with Jenny in the past and we look forward to employing her services today and in the future.
Prof. Dr. Jörg Breitkreutz
Dr. Walsh has recognized expertise in pediatric product development and establishing strong relationships and collaborations through external networks which allows her foresight in global regulatory trends in pediatric product development. Through exhaustive research and analysis Dr. Walsh demonstrated her expertise and strong scientific rationale in identifying API-compatible and pediatric-friendly excipients for stability screening, that ultimately led to successful manufacturing of clinical trial material and won the approval of many regulatory bodies to start clinical trials in the pediatric population.
Her communication to the sponsor and Contract Research Organization (CRO) is prompt and clear, I would recommend Dr. Walsh to your organization as a CMC consultant without any reservation.
Senior Director, CMC Development
Over the last 2 years Jenny has provided an exemplary Regulatory consultant service for us as our company has continued to grow and we have needed the flexibility of consultant support. Jenny worked on a significant project for us bringing a wealth of knowledge and meticulous attention to detail to deliver high quality work within demanding deadlines which has enabled the project to remain on track. Her quality of communication and engaging personality meant that she was able to integrate into the small project team very quickly and provided valuable guidance in helping us establish ways of working to assure clearly defined deliverables within the project.
Jenny has worked in a global capacity on a variety of complex CMC and labelling documentation during the project and always delivers her work to the highest standards and with good humour despite some challenging deadlines and changes in scope of the work. It has been a pleasure to work with Jenny over the last 2 years and I look forward to employing her services again in the future.
Regulatory Project Manager
The pharmaceutical studies for which Dr Walsh provided support were undertaken over a period of about one year and throughout that period Dr Walsh was available for discussion, opinion and advice on how to carry out these studies. Her depth of scientific knowledge was more than sufficient for those studies and her scientific advice was found to be very reliable and logical.
There were never any issues regarding promptness of responses or review of documentation. Her reliability was excellent. Dr Walsh’s communication skills were shown to be at a high level during the many meetings that were held discussing potential ways forward for these studies.