Biomaterials

Biomaterials for soft tissue repair

Added: 13th December 2015

A research group from the University of Manchester asked for regulatory advice during the development of a novel biomaterial for guided repair of soft tissue. The use of scaffolds is a key approach.... View Details

"After confirming the right regulatory classification, Alison provided thorough and understandable guidance to help the development of our novel regenerative medicine scaffold. Systematic and timely explanations of the data needed and options at each stage have led to an optimised pathway to first clinical trial in man."

Adam Reid MBChB FRCS (Plast) PhD - NIHR Clinical Lecturer - University of Manchester

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

A biomaterials approach to regenerative medicine

Added: 11th August 2015

The use of novel biomaterials to guide and stimulate tissue repair is a major approach in regenerative medicine, allowing the developer to engineer desirable characteristics into a material. In par.... View Details

"I have had the pleasure of working with Alison Wilson for the last few years and will continue to do so. Alison has been instrumental in providing valuable regulatory advice to our translational clinical project. Her significant expertise along with her proficient ability to rapidly comprehend the products we are delivering has led us to successes in our project. Alison is professional and able to concisely communicate with people from a wide range of disciplines and areas."

Sarah Cartmell PhD - Professor of Bioengineering - University of Manchester