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 enabled 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.