Clients that made the strategic decision to fully outsource regulatory operations and submission publishing have chosen Exalon to manage and host their complete eCTD lifecycles in a “submission hosting” model on a long-term basis. This established and proven approach enables our clients to

  • Start with eCTD submissions right now
  • Focus on regulatory core competence
  • Be flexible with regard to use of resources
  • Build up a long-term relationship with a reliable partner

“Submission Hosting” by Exalon saves the effort and related cost for

  • Software vendor selection, software licenses and maintenance costs
  • System implementation and ongoing validation of systems (and processes)
  • Hiring and/or development of specialized staff

We provide flexible connections between the client´s infrastructure and Exalon`s publishing system environment. We ensure efficient and highly secure exchange of documents, study data and metadata in a strictly controlled way without compromising any functionality.

With our “Submission Hosting” service we can act like an internal department, extend your capabilities, and free your internal resources.