Create, validate, publish, view and manipulate regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities. Various tools included in the package ensure your work continues flawlessly.
Built in validation supporting regional rules ensures no invalid submissions can be generated.
Fire-and-forget. No need to know anything about eCTD XMLs and other IT-related eCTD/NeeS aspects. NeeS TOC files auto-generated and optimized.
As easy as breathing. Understand and manage your eCTD products lifecycle as simple as "assign-operation-target".
Understand how Authorities see your electronic submission. Reduce review times, increase response times to Agency requests, and ensure faster approvals for your products.