Regulatory

Our regulatory team can shape your programmes and data capture to ensure approvals are gained in the most efficient way at every stage of your therapy – from early stage through to clinical trial and licence.

The novelty of cell and gene therapies means that the need for advice and assistance in the regulatory area is particularly high. Cell and Gene Therapy Catapult are committed to accelerating the development of promising cell and gene therapy products through to clinical trial and licensing and have been working with the regulatory authorities in the UK and Europe to provide clarity in this important area.

Our team have knowledge in regulations across the entire value chain for cell and gene therapies, from procurement of blood, tissues and cells, to specialist manufacture, clinical trial, release and supply.

  • Our regulatory team underpins and supports most of our other capabilities.
  • We have a deep expert knowledge and understanding of the medicinal regulations and guidance that exist specifically for cell and gene therapies.
  • We also work closely with stakeholders to improve regulatory environment for cell and gene therapies which means we are well informed to advise you.

Keep up to date with regulatory news

Our regulatory team have extensive experience in regulatory submissions in cell and gene therapies throughout Europe and in approaching and working with regulators. They understand the specific risks in cell and gene therapy development and can advise on how to minimise those risks to satisfy regulations. The team has native language speakers of the majority EU countries which makes it much easier to discuss requirements with authorities.

The regulatory team

  • The 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, ISCT and CCRM.
  • Director is a co-chair of the ARM regulatory committees (European and international).

How we can help you

  • 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. 

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