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The pharmaceutical company must have the infrastructure and processes in place to handle electronic-only eCTD submissions to successfully support the related decision-making processes for the authorisation of medicinal products within the European Union.

Assion can help you prepare submissions in eCTD (or NeeS) and submitting these to the relevant Regulatory Agencies. We can tailor our services for your company to include; Centralised (CP), Decentralised (DCP) and Mutual Recognition procedures (MRP), as well as National applications and the subsequent maintenance of the lifecycle including:

  • Initial application / Supplementary information
  • Variations /Renewals
  • Periodic Safety Update Reports (PSURs)

Assion uses Exteedo as its Submission Management System, for the publishing and management of regulatory documentation. Exteedo is widely used both in industry and regulatory agencies for eCTD and non eCTD electronic submission (NeeS).

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Old molecule for a new indication an Assion case study

A US start-up business, specialising in the field of gastroenterology, was looking to repurpose an old molecule for a new indication encompassing a different route of administration.