Case Studies

Preparation of an EU regulatory strategy plan for a US client

published 6 Sep 2021

Project based on:

Preparation of an EU regulatory strategy plan for a US client.

Company Description:

Small US-based company focused on developing gene therapy products using a platform designed to overcome the limitations of current gene therapy approaches.

Support required/Problem statement:

Preparation of an EU regulatory strategy plan for a US client with little/no experience of EU regulatory requirements and procedures, or incentives available, for advanced therapy medicinal products (ATMPs).

Scope/added complexity:

  • Identification of a strategy appropriate for a new ATMP gene therapy platform and products utlilising the platform.
  • The client’s lack of previous EU regulatory experience meant that the plan needed to be aimed at the correct level of understanding.
  • Evolving EMA procedures, meaning that during preparation the strategy plan needed to, and continues to require, monitoring to ensure that it remained/remains current.


All client discussions conducted remotely, via email or teleconference.

Activities to date/Issues resolved:

  • Initial “brainstorming” and production of an outline strategy plan.
  • Research via the EMA website and other relevant sources to identify any further applicable processes, and to ensure that the current requirements for each of the processes were fully detailed.
  • Drafting of the strategy plan and circulation for comment within the RRL regulatory team.
  • Finalisation of the strategy plan and delivery to the client, with the option for further discussion/clarification as required.
  • The client is now progressing through the procedural steps included in the strategy plan, with RRL’s continued support.
  • To date, EU SME status has been awarded via the EMA, an ATMP classification application is in preparation, and EU and MHRA scientific advice procedures have been discussed further and are under consideration.

Additional Information:

Reporting to: Senior Vice President, Head of Regulatory Affairs & Quality.

Duration of contact: ongoing since December 2018.

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