Regulatory Affairs for Advanced Therapies

Welcome to CellData Services, a specialist regulatory affairs consultancy in Advanced Therapy Medicinal Products (ATMP) and regenerative medicine. Our aim is to provide a professional and flexible approach to regulatory affairs advice in our key areas:

  • Advanced Therapies: tissue engineering, somatic cell therapy and gene therapy medicinal products

  • Drug-Device Combination Products

  • Biomaterials for regenerative medicine applications

Services

We offer a full range of regulatory services including:

  • Classification advice – is your product an ATMP, a medical device or other product?
  • Assessment / gap analysis of data packages against EU requirements for Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) 
  • Strategic advice on development plans
  • Data summary and document writing
  • Clinical Trial Applications
  • Preparation for Scientific Advice procedures with EMA and national Competent Authorities
  • EMA classification and certification procedures for ATMPs 
  • Regulatory aspects of grant applications
  • Clinical investigations for biomaterials

CellData Services is registered with the European Medicines Agency as a Small/Medium-sized Enterprise (SME). Through us, clients based outside the EU/EEA may be able to access the fee reductions and support incentives for development of advanced therapies offered by the EMA.

Regenerative medicine is a rapidly growing area of endeavour and much translational research and early clinical development is taking place in the academic sphere rather than in commercial companies. It is critical that academic researchers can access expert regulatory advice early in development, and with this in mind we offer tailored training and support to university groups and academic spin-outs. Take a look at the University Support page for more information.

Recent Projects

Clinical Development of A Drug-Device Combination

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 approved separately in the EU but for different indications and intended purposes. CellData Services was p...

Read case study | All Combination Products case studies

Allogeneic MSC for tissue engineering

CellData Services is developing a long-standing collaboration with a UK-based regenerative medicine company, providing regulatory affairs support and expert guidance on a long-term basis. The company is adapting their core tissue engineering technology from autologous to allogeneic cells. This is a...

Read case study | All ATMPs case studies

EMA Scientific Advice for US-based somatic cell therapy

CellData Services was asked to provide a detailed assessment of the data available on a US-based somatic cell therapy for neurological disorders. As this product was at a quite advanced stage in its development for the US market, it was important for the client to gain an understandin...

Read case study | All ATMPs case studies