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.
Coping with the latest eCTD requirements requires well designed business processes supported by a thoroughly planned and controlled IT infrastructure.
We support you with the following services:
Workshops and Training
Evaluation of business processes / gap analysis
Optimization of workflows and business processes
Assessment of user requirements
Vendor selection support
Computerized system validation support
The generation of eCTD-ready documents often turns out to be more time consuming than the eCTD publishing itself. In order to pass technical validation at regulatory agencies you have to consider a long list of tedious technical and formal requirements.
Exalon supports you by making your documents
your processes truly eCTD-ready by providing the following services:
eCTD Readiness Assessment:
Assessment of your regulatory documents regarding eCTD compliance
Review of internal document templates and style guides
Provision of eCTD templates
PDF Rendition settings
Document Processing and Formatting
Publishing of complex and composed documents like ICH E3 study reports
Conversion of paper dossiers to eCTD incl. scanning and text recognition of paper documents (from single volumes to large scale submissions)
Bookmarking and hyperlinking of PDF documents incl. CRF bookmarking and hyperlinking per domain and visit (as per FDA requirements)
Formatting of Word documents
Transfer of labeling information into XML based SPL files for U.S. eCTDs