As the FDA deadline for eCTD submissions approaches and the complexity of drug development continues to increase, life sciences companies need sophisticated and easy to use tools that help them produce submission-ready, quality content in a timely manner. By combining document creation, dossier management, product registrations, and health authority interactions in one place, life sciences companies can increase the speed, efficiency, agility and compliance of their regulatory teams.
More than just a dashboard, the Regulatory Navigator is an intelligent and flexible workspace that brings submission planning and tracking with document authoring and collaboration.
Whether you’re creating documents, managing dossiers, tracking product registrations or managing interactions with the regulatory agencies, the Regulatory Navigator allows regulatory teams to quickly identify all available, expected, in-process or missing submission documents by products, regions, countries, applications or sequences.
Centralizing submission planning with content creation significantly increases the speed, efficiency, agility and compliance of your regulatory team—allowing you to get products to market faster.
Navigate Through All of Your Submissions
in One Interface
Users can navigate across hundreds of thousands of regulatory content from a single centralized location, enabling them to quickly identify all available, in revision or missing content. You can navigate through your submission by product, region, application and sequence or by eCTD Module and Section making it easy to see subsets of regulatory content quickly and intuitively.
Modify Document Metadata Interactively
Navigate Your Regulatory Structure Intuitively
Find Regulatory Content Through Dynamic Filtering and Search
Whether you’re creating a submission from scratch or following an existing template, populating content in the navigator is effortless. Users simply select the document types for the application they’re looking to create and the Navigator automatically generates the submission structure for them, creating placeholders for the documents you’ll need to complete that specific submission.
Create Submissions from Pre-Defined Templates
Pre-Defined Submission Structures for Each Region
Know What Documents You Need with Pre-Populated Placeholders
Sharing documents across applications and sequences is also a breeze, allowing you to easily push documents to multiple sequences in one easy action. Simply create the submission you need, and add content from RegDocs Connect in just a few clicks!
Select Active Submissions and Add Content Easily
Reuse Existing Content from other Applications in your New Submissions
Apply Metadata to Classify New Documents that You Include