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Clinical Trial Applications

Areas of support include:

  • CTA project management
  • Document authoring and coordination
  • Competent authority submissions
  • Ethics submissions
  • GMO applications

This phased approach includes:

  • Preparation and submission of clinical trial applications and following amendments to the competent authorities and to the ethics committees; check the progression of the applications until approval
  • Data entry on behalf of the sponsor into the EU databases for clinical trials

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On demand regulatory team an Assion case study

A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.