Speed up submission readiness while getting more visibility into the status of regulatory activity. Get the RIM platform built for leaner regulatory affairs teams and transform your regulatory intelligence environment today.
Respond faster to the evolving regulatory landscape while improving key regulatory submissions and publishing processes. RegDocs Connect enables teams to deliver reliable regulatory content with data integrity and compliance built in from the onset.
Quarterback global regulatory operations from a central regulatory information management environment, increasing collaboration and regulatory compliance internally and externally. RegDocs Connect is the platform of choice for regulatory professionals in smaller teams.
Unified regulatory information management
Plan, execute, and track regulatory content development and data in a single RIM interface. RegDocs Connect has built-in automation and full support for all major eCTD submission requirements that enables your RA teams to accelerate speed to market across your portfolio.
Automate the development of submission content plans
Associate content to multiple submissions
Aligned with eCTD & EDM Reference Model
Centralize a global team
Securely store your regulatory data in one unified platform. RegDocs Connect allows you to drill down and narrow in on the exact source of delays. Take action directly from the regulatory navigator dashboard to address holdups quickly and ensure your regulatory affairs team stay on track with submission deadlines.
Document import, creation & collection
Aligned to eCTD & EDM reference model
Interactive dashboards & reporting
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Try to change your choice
Historically, TMF filing has had its fair share of challenges. Collaboration between partners, inefficient processes, lack of insight into important metrics, but most of all, manual, arduous, and painful. Let's take that process from headache to happy place with built in workflows, and easy to use filing and indexing features!
Compliance drives everything that we do, and part of that process involves making sure that employees are trained on all SOPs, at all times. Sounds tedious, right? Not with a robust quality system in place!
Document lifecycles, version control, collaboration, approvals... Sound like a headache? It shouldn't be. This demo will showcase a streamlined and compliant approach to managing critical documents and data throughout their lifecycle
Traditional document management lacks the standardization, centralization, and robust processes needed to give you the peace of mind that your TMF is inspection ready. Leveraging review and QC workflows within eTMF Connect resolves this issue and also gives you some time back to do the things that you really need to do for trial management.
Where is that change control form? Whose desk is it sitting on? Who needs to sign it? Why does it take forever to close out a change control request? Sound familiar? Let's take a look at how our Change Control module can digitize and streamline this critical process.
Is your manager asking you for study KPIs again? Or maybe the sponsor you are working with is looking for increased oversight on an all-important study? Whatever the case, let's take a look at some of the built-in reporting of eTMF Connect.
Deviations happen. So do dropped boxes. Audits and complaints, too. Let's look at how we can track all of these events in one centralized location, and how we can manage the CAPA process if need be!
Author productivity accelerated
Centralize collaboration with a full document management system. RegDocs Connect is a fully next-generation regulatory intelligence platform designed to modernize the development of submission ready documents across your entire organization, including RA teams, central leadership, local affiliates and internal clinical, safety and quality teams.
Document template management with Word integration
Review & approval
workflows on documents
Correspondence & commitment management
Maintain pace with health authorities by streamlining correspondence and commitment tracking, ensuring the capture and response are managed efficiently in one location. Paired with robust notifications and task creation, you can put your submission interactions on autopilot.
Create and delegate commitments
Track ongoing activity progress
Author to archive
Centralize your author to archive process by storing previously submitted sequences in the submissions archive. Navigate through our built-in eCTD XML file viewer in the exact format the regulatory authorities will view in.
Navigate through content as the health authorities would
Reuse and reference existing submission content in future
Built-in eCTD viewer for completed regulatory activities
A RIM system, or regulatory information management system, is designed to help pharmaceutical and medical device companies streamline the organization of regulatory submission activities, ensuring the associated documents are organized into sequences. Functionality of RIM systems vary, but these tools largely focus on managing the life cycle of documentation supporting regulatory submissions, complying with regulatory requirements as well as centralizing communications between sponsors and health authorities.
Regulatory information management software often includes robust document management functionality, but capabilities vary so be sure to evaluate the type of RIM system you need to support your regulatory operations. RIM systems that provides functionality that support the drafting and finalization of submission ready documents will provide sponsor teams with a more connected and centralized environment for managing regulatory processes.
Montrium’s RIM system allows for the complete and secure planning, development, and management of regulatory submissions. Improve regulatory processes, monitor global regulatory activities, and keep track of submission status in a single cloud based platform.
Users of RegDocs Connect can streamline the development of regulatory submissions in accordance with all applicable regulatory standards and organize content according to ICH eCTD. Having your content already aligned to the eCTD structure allows for easy content export and portability to existing systems for backbone development and eCTD publishing.
Improving regulatory compliance starts with ensuring your entire regulatory affairs team is on the same page, having access to up to date information regarding health authority interactions and regulatory activities. Providing access to real-time submission information, reports and insights into active processes gives RA teams the visibility they need to make the most informed decisions.
As a cloud-based RIM solution, RegDocs Connect takes security and data protection very seriously. We ensure your regulatory submissions are stored securely through the use of multiple layers of physical and operational security, encryption, firewalls, intrusion detection, and prevention systems. We also regularly undergo security audits and assessments, as well as achieve a number of recognized compliance certifications to comply with all relevant laws and changing regulations.
While many regulatory information management (RIM) platforms share a lot of the same functionality, RegDocs Connect provides a robust set of document collaboration functionality to optimize author productivity. When paired with our regulatory intelligence and submission planning tools, RegDocs Connect becomes the command center for your entire regulatory affairs team.
RegDocs Connect is also specifically engineered for smaller teams that are looking to scale. Other larger platforms like Vault submissions or Veeva Vault submissions publishing are typically designed for larger organizations and require significant support to implement and configure.
We’ve developed a tried-and-tested methodology for implementing our regulatory information management platform, designed to reduce burden, speed up timelines and maintain compliance.
Looking for more information on what bells and whistles to expect in RegDocs Connect? Explore the full breadth of functionality provided here.
Montrium RIM is part of the larger Montrium platform. Learn more about the industry’s leading intelligent content management platform.
A company is only as exceptional as its customers. Luckily for us, we have more than a few of those. Take a look at some of the incredible organizations we're proud to call not just our customers, but our partners.
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