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Regulatory Affairs

Streamline your regulatory processes & get products to market faster 

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Trusted by thousands of regulatory professionals globally

Top regulatory affairs leaders leverage Montrium to hit their goals

every day
every week
every month

Streamline author productivity 

Gain visibility into your entire team’s activity and drill down into individual submissions

Improve collaboration with external stakeholders, local affiliates, and partners

Diagnose exactly what might be impacting timelines

Monitor dossier development 

Ensure documentation is moving forward as planned

Identify potential blockers that may impact milestones earlier

Leverage insights to adjust submission plans

Plan & adjust regulatory strategy 

Get a holistic view of your global regulatory efforts

Manage and monitor your regulatory portfolio

Leverage insights from previous submissions to adjust regulatory strategy

When initially uploading documents and comparing them to the system’s placeholders aligned with the DIA’s TMF Reference Model, right away we could see in the eTMF Connect Navigator what was effectively complete, any documents we were missing, and any titles that needed to be named differently.

Gina Varner

Director of Regulatory Affairs

Packed with tools for the entire regulatory team

DOSSIER DEVELOPMENT
Medical Writing
Regulatory Affairs
Regulatory Leadership
Submission readiness reporting 
Correspondence management 
Commitment tracking 
Global submission planning 
Collaborative editing and reivew
Automatic task distribution
Native integration with MS Word
Tracked changes, redlining, & comments
Submission templates & structures
eCTD viewer for submitted sequences
Content portability to publishing software 
Full audit trails & version control 
Submission readiness reporting 
Global view of regulatory activity 
Product and indication database 
Submission archive 

Top resources for regulatory affairs

Guide
Clinical Operations
CFO Pitch Guide
The CFO Pitch Guide is your playbook for executive conversations. Learn how to translate clinical tech benefits into CFO-ready messaging that drives clarity, confidence, and buy-in.
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Guide
Clinical Operations
TMF Toolkit
This TMF Toolkit is a curated collection of useful links, tools and resources compiled by TMF subject matter experts to support the TMF community. Whether you're new to the TMF space or a long-time pro, this living document is designed to grow with you. Bookmark it and check back often for new content and updates.
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White Paper
IT
Adobe Acrobat Sign-Shared Responsibilities for CFR 21 Part 11 and Annex 11 Compliance
In collaboration with Adobe, we’ve published a detailed white paper exploring how Acrobat Sign Solutions supports compliance with 21 CFR Part 11 and EU Annex 11, and what your organization must do to stay audit-ready. 
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Report
Clinical Operations
State of TMF Industry Report 2025
Read the report everyone's talking about! With insights from over 500 TMF professionals, you won't want to miss this.
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White Paper
Clinical Operations
Building a Risk-based TMF Management Framework
In this first-of-its-kind white paper, Montrium's experts detail their new methodology for risk-based TMF management. It goes beyond simply explaining the theory behind risk-based approaches to providing worked examples that illustrate how you can implement this model within your own organization.
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Report
Clinical Operations
The State of TMF Industry Report 2023
The State of TMF Industry Report 2023 is the largest report of its kind, featuring proprietary data collected from 245 TMF professionals and analyses from Montrium's seasoned experts.
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Guide
Clinical Operations
Guide to Sponsor vs CRO-owned TMF Systems
Our free guide breaks down the advantages and disadvantages of owning a sponsor eTMF system vs a CRO-owned eTMF system.
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Template
Clinical Operations
eTMF Request-for-Information Template
Our free RFI template helps get all of the critical criteria you need to evaluate eTMF software vendors.
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Guide
Clinical Operations
Guide to Bringing TMF Management In-House
Discover what it takes to get from A-to-Z and manage your TMF internally with our free guide.
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Guide
Clinical Operations
The Complete Guide to Buying eTMF Software
This guide will help select the right eTMF solution for your team with expert guidance and advice.
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Checklist
Clinical Operations
The Ultimate Checklist for Inspection Readiness
Our TMF checklist will provide you with a clear action plan as you prepare for your inspection.
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Report
Clinical Operations
COVID-19 and TMF Management Report 2020
The report includes the results of our COVID-19 and TMF Management Survey, with views representing a wide range of industry stakeholders, including pharmaceutical and biotech sponsors, and CROs.
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Guide
Regulatory Affairs
The Complete Guide to Buying RIM Systems
This buyer’s guide is designed to help you step-by-step towards selecting the right regulatory EDMS solution and vendor.
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Checklist
Procurement
GxP Software Vendor Selection Checklist
Not sure where to start when it comes to selecting the right software for your business? Check out this free checklist.
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Template
Clinical Operations
eTMF Business Case Template
Build a powerful business case internally for implementing an eTMF at your organization with our FREE template!
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Template
Clinical Operations
Template - Paper-based System Cost Calculator
Our customizable Paper-Based System Cost Calculator lets you input a few basic metrics, and in minutes can tell you the total annual cost of your paper-based system.
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Checklist
Quality Assurance
IT SOP Checklist for Life Science Companies
The SOP checklist includes a full list of procedural documents needed, information on their function and purpose, and how to get them in place.
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Guide
Clinical Operations
eTMF Implementation Planning Workbook
This checklist has been designed as a self-guided preparation workbook to help your company plan a successful eTMF implementation.
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White Paper
Quality Assurance
White Paper - 21 CFR Part 11 vs Annex 11
In this guide, we show you how to approach compliance around computerized systems using both directives, as well as how using GAMP 5 can level the playing field.
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