RegDocs Connect Regulatory Document Management System

An Advanced Regulatory EDMS and Submission 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.

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Global Regulatory e-Submissions

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.

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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

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Significantly Improve Time to Submission

Regulatory Template Management

Template Management

Centrally manage and publish templates for the production of submission-ready documents

Collaborating on Regulated Content

Collaborative Authoring

Real-time collaborative authoring directly in Microsoft Word speeds up the content authoring process

Automate Regulatory Publishing

Automated Publishing

Automated publishing tools allows the creation of TOCs and hyperlinks as well as ICH compliant formatting

Author Documents in eCTD Classification and Integrate with eCTD Software

eCTD Classification + Integration

All content is automatically organized by module and section with native integration with eCTD tools

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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

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Manage Drug Product Documents in eCTD Structure

It’s all about collaboration!

Collaborating on Regulatory Documents in RegDocs Connect

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

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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

RegDocs Connect integrated with Regulatory Submission eCTD Tools