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Horizon Europe EU-funded Programmes

Expert regulatory partner to ensure compliance with regulatory requirements, consortium objectives, maximizing requested benefit and impact.

Horizon Europe EU-funded Programmes

Horizon Europe is the ambitious EU key research and innovation framework programme for 2021 to 2027 with a budget of  €95.5 billion. Their related projects involve an important challenge in terms of management of relationships between partners and their innovative character thereof. They imply development of innovative products that are expressly complex in its nature (tissue engineered products, cell therapies, complex biomaterials, nanomaterials, gene therapy, digital health, among others), research environments, manufacturing conditions and potential health applications, to which specific regulatory conditions apply.

For a project to be feasible for the European Commission, a sustained regulatory support is key to confer projects with consistency according to call standards.

Therefore, in order to ensure a proper profiling and regulatory compliance of the product, from development to potential future commercialization, involving a regulatory partner as Asphalion is of paramount interest when it comes to Horizon Europe, both for grant obtention and for a successful project execution.

Horizon Europe EU-funded Programmes Solutions

Support in proposal preparation as regulatory expert, including:

  • Advice on the alignment of project idea with call text
  • Regulatory work package (WP) design and preparation.
  • Compilation and integration of WPs in the final proposal
  • Support to the coordinator through the proposal writing process


Regulatory activities during project execution:

  • Regulatory roadmap and pathway definition for innovative medicinal products and medical devices for Health applications
  • Early regulatory engagement with regulatory authorities for correct product designation, pre-clinical data validation and definition of best clinical strategy for future product commercialization.
  • Innovation Task Force (ITF) and Scientific Advice (SA) meetings with EMA
  • National Competent Authorities (NCA) meetings
  • Meeting with Notified Bodies (NBs) for regulatory strategy in medical devices
  • Continued assessment on the applicable technical standards, regulatory guidelines and ethical issues during project execution.
  • Elaboration of the regulatory documentation for the preparation of a Clinical Trial application
  • Support in the regulatory requirements for medical devices development for future CE marking

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Why Asphalion?

With more than 150 professionals with scientific and regulatory background, Asphalion is currently involved in 16 European funded projects as global regulatory partners, taking care of the activities during the development of different innovative medicinal products and medical applications, tailored specifically for each call .

Some of these projects include ATMPs development, COVID-19 indicated products, therapeutic vaccines, microbiome products, complex biomaterials and implants, gene therapies or multimodal nanoparticles, among others, all of them oriented towards different stages of the development process from pre-clinical research to clinical setting.

This expertise backs Asphalion as a top-class regulatory partner to fulfill with the requirements that best position the regulatory strategy of your Horizon Europe Consortium.

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