RegDocs365 2026: Benefits, Features & Pricing

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On this page

Overview
Pricing and Plans
Features
Integrations
User Reviews

Overview

RegDocs365

3.8

(18)

Pricing

Starting at $100.00 per month

About RegDocs365

RegDocs365 is an electronic regulatory document management (EDM) system for life sciences. It caters to biotech, pharmaceutical, and medical device companies. The platform offers core features for managing regulatory documents. It provides a centralized repository for documents like FDA 1572 forms, protocols, and SOPs. The system has robust search capabilities to find documents quickly.

Additionally, it also enables version control and audit trails to track document changes. RegDocs365 also allows for secure collaboration between internal and external users. For deployment, RegDocs365 is a cloud-based system accessed via any standard web browser. Ongoing support is provided through an expert customer service team available via phone, email, and chat.

RegDocs365 Screenshots

RegDocs365 Pricing and Plans

Starting price: $100.00 per month

Free Trial

Free Version

Basic

$100.00

flat rate, per month

No plan information available

RegDocs365 Features

Popular features found in Clinical Trial Management
21 CFR Part 11 Compliance
Data Capture and Transfer
Data Import/Export
Document Management
Electronic Data Capture
Financial Management
Inventory Management
Patient Management
Patient Monitoring
Patient Recruiting
Scheduling
Workflow Management
More features of RegDocs365
Access Controls/Permissions
Activity Tracking
Alerts/Notifications
Audit Trail
Clinical Study Management
Compliance Management
Customizable Reports
Data Verification
Digital Signature
Document Storage
Double Data Entry
Drag & Drop
Forms Management
HIPAA Compliant
Real-Time Data
Real-Time Reporting
Third-Party Integrations

RegDocs365 Integrations

Microsoft SharePoint

Workspace ONE

AWS AppSync

RegDocs365 User Reviews

Overall Rating

3.8

Ratings Breakdown

22%

50%

22%

Secondary Ratings

Ease of Use

3.7

Value for money

3.8

Customer support

4.0

Functionality

3.7

Kelvin C.

Verified reviewer

Pharmaceuticals

2-10 employees

Used daily for less than 2 years

Review source

Reviewed September 2024

Chief Operating Officer and SVP Research and Development

Overall very positive experience storing and locating files to ensure secure storage and compliance with regulations

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Secure 21CFR11 compliant document system

Cons:

Can be clunky to use - drag and drop not allowed between RegDocs365 folders. Login can be challenging sometimes and MSoffice365 security can interfere with RegDocs365

Carol M.

Verified reviewer

Pharmaceuticals

2-10 employees

Used monthly for more than 2 years

Review source

Reviewed September 2024

Good if used consistently

If used frequently and regularly I think it would be good. As an infrequent user I have to re-aquaint myself with its use each time

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

A good repository for sharing clinical trial related documentation

Cons:

Password update seems to be slightly more complicated than it need be

Thomas L.

Verified reviewer

Pharmaceuticals

1001-5000 employees

Used weekly for less than 12 months

Review source

Reviewed September 2024

Not yet perfect

The usual task of forwarding completed documents like Medical Monitoring Plans and DMC Charters is fine, but the Relevant Communications management is a pain point, as noted.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

I see no advantages of RegDocs365 over the product that my company usually uses (Trial Interactive).

Cons:

With Trial Interactive, I can forward Relevant Communication emails directly to a Communications module that is study-specific, whereas such emails need to be put in PDF form (very awkward if there is an attachment) before submission to RegDocs365. This is hugely inefficient and fixing this would be a big improvement.

Katie K.

Verified reviewer

Research

51-200 employees

Used monthly for less than 6 months

Review source

Reviewed September 2024

LOVE RegDocs365

Ratings Breakdown

Ease of use

Functionality

Pros:

Efficiency, thus increasing productivity.

Cons:

I wish it was the standard utilized overall.

Sarah S.

Verified reviewer

Research

51-200 employees

Used weekly for more than 2 years

Review source

Reviewed July 2020

RegDocs 365

RegDocs365 is very responsive when trouble occurs. I have used the system for almost 3 years and changes have been made over the years. I like the way the company takes our feedback seriously and works to improve the system overtime.

Ratings Breakdown

Ease of use

Customer support

Functionality

Pros:

I love the bulk upload feature and the ease of the folder structures

Cons:

There are times when the system glitches and is slow running; also the checking in and out of documents can be a bit of a nuisance.

Vendor Response

Thanks for your feedback and we are glad to hear that our support staff is responsive to your needs. We continue to add additional capabilities based on suggestions from our users so if you can think of things that you'd like to see incorporated then please submit a helpdesk ticket and we can see about adding that functionality.

Replied September 2020

Daniel V.

Verified reviewer

Research

10000+ employees

Used other for more than 2 years

Review source

Reviewed July 2020

Honest Review

Ratings Breakdown

Ease of use

Customer support

Functionality

Pros:

I honestly cannot recall anything I liked about using this software.

Cons:

The occasions on which I had to use regdocs365 for work were some my worst experiences with any software in my life thus far. I insisted that the study sponsor which had required us to use regdocs365 instead allow us to use a different method for secure transmission of PHI for review because my use of regdocs35 had been so frustrating and a such a waste of time. I am sure that good people worked to develop this product, but the user experience desperately needs improvement.

Vendor Response

We are very sorry to hear about your frustrations using our software. We have been in the market now for a number of years so it would be advantageous to know if you were using the system recently or in the early days. We've continued to add more functionality to make it easier for our users to enter and report on their documents. We would be very interested in following up with you to see why you had such a bad experience with the system.

Replied September 2020

sanu k.

Verified reviewer

Education Management

1001-5000 employees

Used weekly for less than 12 months

Review source

Reviewed January 2023

it is an advanced planning and scheduling software.

I have had an overall positive experience with RegDocs365. They have an extensive library of documents and templates that are tailored to specific industries and businesses

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

The most impactful features in RegDocs365 include automated document organization and access, powerful search and filtering capabilities, real-time tracking and audit capabilities, secure virtual data rooms, and an integrated electronic signature platform.

Cons:

Features that could be improved in RegDocs365 include better document searching and filtering capabilities, enhanced collaboration tools, automated workflow tools, and integration with third-party products. Integration with existing business processes could be made easier through built-in features such as data mapping, custom email templates, and automated notifications

Shuai L.

Verified reviewer

Biotechnology

501-1000 employees

Used weekly for more than 2 years

Review source

Reviewed July 2020

Good system to manage documents

Ratings Breakdown

Ease of use

Functionality

Pros:

Overall very nice layout. Very easy to find documents due to the very organized and visual structure.

Cons:

Some functions are not very easy to use, e.g. Bulk download will remove all the folder structures.

Vendor Response

Thanks for your feedback and we'd love to follow up with you to understand the specific issue that you ran into as we are sure that we can overcome that particular mechanism. We've also added a number of new features that should enhance the ability to see and report on those documents.

Replied September 2020

Bertina W.

Verified reviewer

Research

11-50 employees

Used daily for less than 12 months

Review source

Reviewed July 2020

Site Overview of System

would like a smoother system

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Able to download documents and go back and correct them

Cons:

Long process it is complicate to get use to system

Vendor Response

Thanks for your feedback and we would love to speak with you about your experience so that we can provide a more streamlined solution for you. We continuously add new functionality based on user feedback and we strive to enable the easiest system to use.

Replied September 2020

Verified

Reviewer

Research

201-500 employees

Used other for less than 12 months

Review source

Reviewed August 2020

still figuring out nuances