An Advanced Regulatory Submission Management Solution
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RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions.
Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution.
Helping You Navigate the New Regulatory Landscape
With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content in a timely manner has become paramount to commercial success. By centralizing document authoring and review, and improving collaboration between different contributors, it is possible to significantly improve the production of regulatory documents. Automation of publishing tasks and mapping to relevant regulatory standards and models further facilitates the creation of content to be included in your submission sequences.
Montrium has a deep understanding of both the drug development landscape and regulatory submissions which has formed the basis of our RegDocs Connect solution. RegDocs Connect helps you author and manage your content both pre and post-submission in an intuitive, easy to use and compliant environment.
Perfect for
- Pharmaceutical Companies
- Contract Research Organizations
- Regulatory Publishers
Built to
- Ensure all documents are submission ready
- Streamline submission document review and approval
- Improve author productivity for submissions
Take the tour
Significantly Improve Time to Submission
Template Management
Centrally manage and publish templates for the production of submission-ready documents
Collaborative Authoring
Real-time collaborative authoring directly in Microsoft Word speeds up the content authoring process
Automated Publishing
Automated publishing tools allows the creation of TOCs and hyperlinks as well as ICH compliant formatting
eCTD Classification + Integration
All content is automatically organized by module and section with native integration with eCTD tools
Centrally Build and Manage Regulatory Documents
Predefined Configuration
RegDocs connect comes preconfigured with all of the different types of regulatory document types and metadata needed
Intuitive Navigation
Pre-defined document structures based on the EDM Reference Model or eCTD makes finding documents easy
One Version of the Truth
Versioning and collaborative authoring and review ensures that everyone works from the same document
Configurable Workflows
Our configurable workflow engine allows you the latitude to decide document lifecycles directly in the user interface
It’s All About Collaboration
Adaptive Workflows
RegDocs Connect allows you to define which workflow steps need to be undertaken per document type
Real-time Document Collaboration
Native Microsoft Word collaboration tools combined with our SharePoint foundation allows for realtime collaborative editing and commenting of documents
Task Management
Aggregated task management allows you to be in control of your tasks and see where everyone else is in the collaborative authoring and review process
Integrate and Push Submission Content to eCTD Platforms
Connect Records Center
Native SharePoint functionality files and stores final records in a SharePoint Records Center. Regulatory documents can be viewed in an eCTD hierarchy making it easy to find content
Manage Submitted Sequences
Once your sequence is built and submitted you can store it in RegDocs connect for archiving and future reference
SharePoint Connectors
Most mainstream eCTD vendors have developed SharePoint connectors which can link up to the Records Center of RegDocs Connect and pull submission ready content and metadata directly into sequences
Manage Regulatory and Clinical Content in One Place
Eliminate Duplicate Records when you connect RegDocs Connect & eTMF Connect
Other Strong Core Features & Functionality
Document Versioning
Integrated document versioning allows you to go back in time to see all previous versions of documents
Mobile Notifications
Get notification of collaborative tasks on all of your devices
Drag & Drop Functionality
Drag and drop documents directly into the interface or through windows explorer
Business Intelligence & Dashboards
Smart dashboards and strong reporting features allow you to access and analyse information fast
Centralized Collaboration
All study stakeholders collaborate through workflows and access content in one central place
Intelligent Workflows
Adaptable and Intelligent workflows based on document type and roles
Web Application
No software to install on users computers and fully integrated with Microsoft Office
Iron Tight Compliance
Fully documented and tested in line with 21 CFR Part 11, Annex 11 and GCP
Aligned with ICH eCTD
All documents are automatically mapped to the correct module and section of eCTD for easy submission building