Regulatory

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)

Example projects

Gene therapy registration  Tissue engineered trachea

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.

Our team has led meetings with the MHRA to help ensure the smooth licensing of the trial in the UK for an ultra-orphan tissue engineered product. To help further, they met with the EMA to help determine the best route to marketing the product in Europe.

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. 

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