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About

RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website.

About

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. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Medical Devices, Pharmaceuticals, and IVD companies

Audience

Operational and regulatory teams looking for a toolkit to prepare complete and compliant submission ready documents and records

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 5.0 / 5
support 5.0 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

RegDesk
Founded: 2014
United States
www.regdesk.co

Company Information

Montrium
Canada
www.montrium.com

Alternatives

Alternatives

LifeSphere RIMS

LifeSphere RIMS

ArisGlobal
Rimsys

Rimsys

Rimsys Regulatory Management Software
KnowledgeNET

KnowledgeNET

Sarjen Systems
Redica

Redica

Redica Systems
GlobalSubmit

GlobalSubmit

Certara
RIMTrack

RIMTrack

WinWire Technologies

Categories

Categories

Document Management Features

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Integrations

Active Directory
Arena
Asana
Boomi
Dynamics 365 Customer Service
Jira
Montrium Connect
MuleSoft Anypoint Platform
Okta
OpenText AI Operations Management
Oracle ADF Faces
PTC Windchill
Qualio
Resource Management by Smartsheet
SnapLogic

Integrations

Active Directory
Arena
Asana
Boomi
Dynamics 365 Customer Service
Jira
Montrium Connect
MuleSoft Anypoint Platform
Okta
OpenText AI Operations Management
Oracle ADF Faces
PTC Windchill
Qualio
Resource Management by Smartsheet
SnapLogic
Claim RegDocs Connect and update features and information
Claim RegDocs Connect and update features and information