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.

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Manipulate

Behind the scenes: easily split and merge your PDF documents, convert MS Word DOC to PDF, define document Titles, attributes, granularity, envelope values...

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Compile

Prepare you submission documents and fill in the provided regional-aware approved template. Add documents manually or import/merge an existing eCTD/NeeS.

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Validate

Built in validation supporting regional rules ensures no invalid submissions can be generated.

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Publish

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.

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Manage Lifecycle

As easy as breathing. Understand and manage your eCTD products lifecycle as simple as "assign-operation-target".

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View

Understand how Authorities see your electronic submission. Reduce review times, increase response times to Agency requests, and ensure faster approvals for your products.