Manage submission document lifecycle across departments in one place using innovative authoring and intelligent taxonomy features. The NextDocs submission management provides template based authoring capabilities with full metadata integration, simplifying the electronic submission management process.

Orchestrate your submission document lifecycle with a dedicated lifecycle management engine and sophisticated visual workflow functionality to ensure on-time authoring, review and approval of crucial submission documents.
Manage all submission documents with full 21 CFR part 11 compliance and take advantage of electronic and digital signature capabilities meeting international regulatory requirements and standards.

Start tagging your crucial regulatory documents of all modules with eCTD metadata right when your team is creating the file easily and painless. Working upstream when you author or request a new document, rather than waiting until the document needs to be published.

Tear down information silo’s and connect all departments involved in regulatory submission activities or needed to provide relevant information for your submission. Collaboration of all departments and having them contribute into one global repository utilizing a common language based on standard taxonomy and pre-defined templates, will ensure perfect quality and consistency of all your regulatory documents, reducing the need of last minute adjustments to your documents, to harmonize them.

Easily visualize your regulated documents the way you need them to be without changing their structure or location in the system, so your business is able to find and assemble the documents needed for a submission with ease, applying individual submission views to your crucial documents across the repository. This will eliminate forgotten documents or cases where the wrong version or file has been submitted to the agency.

NextDocs introduces and provides content authoring concepts like Intelligent Content and Connected Content through their Regulatory Solutions providing your business and users with the tools to succeed in a high pressure and strictly regulated business environment, to concentrate on what matters: Getting your submission documents submitted correctly and be fully compliant.  
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