Home
/
Regulatory Affairs

Streamline your regulatory processes & get products to market faster 

Chat with an expert
Chat with an expert
Request a demo
Request a demo

Trusted by thousands of regulatory professionals globally

Zydus logo
Siron Clinical logo
SignalChem LifeSciences
Pharmascience logo
Orphazyme logo
Oncobay logo
Obviohealth logo
MAPS Public Benefit Corporation logo
InforRLife logo
Immune Biosolutions logo
Illingworth logo
HungaroTrial CRO logo
EpicentRx logo
Entos Pharmaceuticals logo
Easthorn logo
Criterium logo
Ambel Biosolutions logo

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

Report
Quality Assurance
The State of AI in Clinical Quality [2026]
Regulatory uncertainty. Skills gaps. No clear governance owner. The barriers to AI in clinical quality are real, and fixable. Get the data, insights, and practical recommendations in our 2026 industry report.
Text Link
Learn more
eQMS Audit-readiness checklist covereQMS Audit-readiness checklist cover
Guide
Quality Assurance
Audit-ready QMS inspection checklist
Use this checklist to assess your quality management system against what regulatory auditors expect to see, and identify gaps before they do.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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. 
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
Template
Clinical Operations
eTMF Business Case Template
Build a powerful business case internally for implementing an eTMF at your organization with our FREE template!
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
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.
Text Link
Learn more
01 / 05

Ready to get started?

Get the latest news and product updates delivered straight to your inbox.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Montrium eTMF

eTMF ConnecteTMF Connect features

Montrium RIM

RegDocs ConnectRegDocs Connect features

Montrium QMS

Quality ConnectQuality Connect features

Modules

Document controlTraining managementCAPA managementChange control

Platform overview

Platform overviewPricingMontrium FAQTrust centerBook a demo

Acrobat Sign Validation Services

Adobe Acrobat validation servicesFree Adobe Acrobat validation pack

Company

AboutContact usNewsroom

Resources

BlogThe State of AI in Clinical QualityDemo centerResource centerPodcastsWebinarsEvents

Contact

Montrium Headquarters
507 Place d’Armes, #1500
Montreal, QC H2Y 2W8, Canada
+1.514.223.9153
Montrium Europe SRL
Rue de la Pépinière, 14-1
1000 Brussels, Belgium
+32.2.808.3008

Contact

Montrium Headquarters
507 Place d’Armes, #1500
Montreal, QC H2Y 2W8, Canada
+1.514.223.9153
Montrium Europe SRL
Rue de la Pépinière, 14-1
1000 Brussels, Belgium
+32.2.808.3008
Montrium logo
Montrium Inc. All rights reserved, 2026  
Terms and ConditionsPrivacy Policy
Montrium
Montrium eTMF
eTMF ConnecteTMF Connect features
Montrium QMS
Quality ConnectQuality Connect features
Modules
Document controlTraining managementCAPA managementChange control
Platform overview
Platform overviewPricingMontrium FAQTrust centerBook a demo
Montrium RIM
RegDocs ConnectRegDocs Connect features
Resources
The State of AI in Clinical QualityDemo centerResource centerPodcastsWebinarsBlog
Montrium by industry
Non-profitMedical deviceCROPharma / Biotech
Montrium by team
Clinical operationsRegulatory affairsQuality and complianceIT & security
Company
AboutContact usNewsroomEvents
Partners
PartnersTechnology partnersCo-marketing partnersService partners
Acrobat Sign Validation Services
Adobe Acrobat validation servicesFree Adobe Acrobat validation pack
Contact
Montrium Headquarters
507 Place d’Armes, #1500
Montreal, QC H2Y 2W8, Canada
+1.514.223.9153
Montrium Europe SRL
Rue de la Pépinière, 14-1
1000 Brussels, Belgium
+32.2.808.3008
Socials
Montrium Inc. All rights reserved, 2026  
Terms and ConditionsPrivacy Policy