The ever-changing nature of cell and gene therapies means that the need for advice and assistance in the regulatory area is particularly high.

Our regulatory team can guide you through the latest medicinal regulations and guidelines that exist specifically for cell and gene therapies.

From helping to shape your programmes to data capture, we’re committed to ensuring your promising cell and gene therapies have the smoothest possible transition, from early stage research through to clinical trial and licence.

With you every step of the way

  • We’ve navigated our way around a wide variety of regulatory submissions throughout Europe, and can help with approaching and working with regulators.
  • There are a lot of specific risks in cell and gene therapy development and can help advise on how to minimise those risks to satisfy regulations.
  • Our team has native language speakers from the majority of European countries which can really help when you need to discuss requirements with local authorities.
Our team have extensive knowledge of cell and gene therapy regulation

Keep up to date with regulatory news

Our European reach

Our team sits on a number of international and national scientific advisory boards.

  • Includes an EU qualified person who can advise on GMP, QMS and certification issues.
  • Have working relationships with MHRA, EMA, HTA, BIA, ARM, FDA and ISCT.
  • Director is a co-chair of the ARM regulatory committees (European and international)

Regulatory Support

Cell and gene therapies face unique regulatory challenges and procedures when compared to conventional medicines. Cell and Gene Therapy Catapult offers support which will enable you to better understand and be equipped to navigate the UK and EU regulatory landscape, from the development stage to clinical trials.

For more information on how we can support you, please click here.

Example projects

Gene therapy registration 

We have worked with clients to file ex-vivo gene modified products in a number of European countries, including securing the correct tissues and cells licensure, GMO,
ethics and regulatory approvals.

We also ensured the procurement centres involved in the trials were approved and had the right licences.

What we can help with

  • Providing gap analysis of the manufacture, trial and control of a product against the quality and safety requirements required for submission of a package to regulatory agency.
  • Coordinating and supporting meetings with regulatory agencies.
  • Preparing dossier(s) for submission to regulatory agencies.

Contact us to find out more about our regulatory capabilities. 

Related Publications

05 April 2022
CGT Catapult Guidance for ATMP
Cell and Gene Therapy Catapult
25 March 2022
Preparing for the future of advanced therapies: The need for a National Cell and Gene Therapy Vision for the UK
Cell and Gene Therapy Catapult
09 December 2021
CGT Catapult Guidance on the development and marketing of ATMPs in the UK and EU at this position post-BREXIT
Cell and Gene Therapy Catapult
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