About Celldata Services

CellData Services is owned by Alison Wilson.

Alison is an independent regulatory affairs consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has 30 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 - Tissue Engineered Medical Products and a member of the British Standards Insititute (BSI) Technical Panel RGM/1 – Regenerative Medicine. As a member of RGM/1, which works to ensure a high level of representation and support for the UK and EU within the international standards community, Alison is closely involved in the development of new documents and guidelines for regenerative medicine and advanced therapies. She is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011 and is a recognised contributor to the BSI cell therapy guidance documents PAS 83:2012, PAS 84:2012 and PAS 157:2015. 

 

Alison has a MSc in stem cell biology and regenerative medicine. She is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA). She is part of the Module delivery team for the TOPRA MSc in Regulatory Affairs (Module 9 – Biotechnology) and was Module Advisor for the MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) from 2006-2012. 

 

Alison presents regularly for major conference producers Management Forum and Informa, and is equally at home delivering bespoke training to small groups including start-ups and university courses. Her publications on regulation of ATMPs and human tissues are listed on the Publications page.

 

CellData Services provides strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products (ATMPs), regenerative medicine therapies, biomaterials and drug-device combination products in the EU. Alison has extensive expertise in guiding smaller companies and academic groups through the regulatory complexities of development of novel regenerative medicine products, in particular scientific advice procedures and first-in-man clinical trials, and in recognition of this has received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.