Combination-products

Clinical Development of A Drug-Device Combination

Added: 14th November 2016

A US-based client wished to conduct a first-in-human clinical trial of a novel drug-device combination product in the UK. Both the medicinal substance and the medical device were well-known and app.... View Details

" With over 10 years of experience of using consultants and other suppliers for all sorts of activities, I can truly say that Alison Wilson is a rare find.  Alison was our UK regulatory consultant for a first in human clinical trial for a combination product.  Our internal project team did not have previous experience with combination products, clinical trials, and let alone the first human clinical trial outside the US.  Alison was critical to our success from the very beginning to the very end of that trial.  What I found to be so commendable about Alison is not just her technical skill and experience that we were hiring her for, but her clear communication style and personal commitment to the project team and overall project success.  Alison on several occasions, made herself available outside business hours to accommodate the time difference between the UK & US and support hitting deadlines.  She took the time to dig into details and truly understand technical data in order to write a strong submission.  She also took the time to not just check the boxes and tell us what to do from a regulatory perspective, but to educate us on the benefits of different strategic approaches and background of the MHRA's potential interpretation.  "

Christine Kearney - Principal Engineer - CareFusion Inc, USA

Classification Challenge

Added: 6th October 2015

A client asked us to assist with classification of a complex novel biomaterial consisting of elements of a medical device, medicinal products and human blood-derived pr.... View Details

"CellData Services did a superb job in helping us to determine the regulatory classification of a complex regenerative medical device. A number of other conflicting opinions had been given which served to confuse the issue. CellData Services worked through the available information to come to a logical and sound conclusion."

Mark Wickham - Principal - Alacrita LLP

Tissue engineering with autologous stem cells

Added: 12th August 2015

Working with a client from initial spin-out from a UK university, we guided development to gain first-in-man clinical trial approval for a novel tissue engineering prod.... View Details

"CellData Services has worked with us since 2007 on the development of our stem cell technology for meniscus repair. Alison has played a vitally important role in identifying and managing regulatory issues and developed the regulatory strategy that led to successful progression to our first-in-man clinical trial. She combines an abundance of expert regulatory knowledge with hands-on practical experience of working within the pharmaceutical industry to help optimise progression of the development programme. Throughout our time working together CellData has been pro-active in supporting our ongoing development programme with clear and detailed input, providing understandable and relevant regulatory guidance at each step. Alison is a delight to work with and we are very happy to continue with her providing expert support for our project."

- Chief Scientific Officer - Azellon Ltd, UK