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About

RegAffairs AI is an AI research assistant for regulatory affairs, compliance and product stewardship teams. You ask a regulatory question in plain language and an agent researches it across 1,046 official regulation databases from more than 340 regulators in 43 jurisdictions, covering chemicals, pharma, food, cosmetics, pesticides, biocides, fashion and EHS. The answer comes back in minutes with every claim cited to the exact regulation, annex entry or judgment paragraph, and each citation opens the stored source document. The research trail, every search and document the agent read, is shown on the page, so the work can be checked and handed to legal. Answers come only from the indexed official text; where the record is silent, the answer says so. Typical questions: is a substance still listed or restricted, what changed after the last amendment, how two markets differ, and who has to notify by when. Questions are never used for training.

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.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Chemical compliance

Audience

Medical Devices, Pharmaceuticals, and IVD companies

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

No images available

Screenshots and Videos

Pricing

$100/month
Free Version Supported
Free Trial Not Supported

Pricing

Contact us to learn more.
Free Version Not Supported
Free Trial Not Supported

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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Reviews/Ratings

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

Pros from Real Users

Pros

  • Comprehensive, user-friendly tool that consolidates all regulatory affairs processes in one place. Excellent support provided by real experts that add value to our business.
  • The User Interface is very elegant and engaging to use. The Global view of Alerts, Standards and Regulations is appealing and consolidated and is a useful tool for regulatory intelligence.
  • RegDesk is easy to deploy, entirely web-based with streamlined user access management. Its UI is intuitive which makes training users simple. Its modular structure reduces complexity for folks working on specific topics, which may not relate to the work of another colleague -- for example, Regulatory Intelligence and market access requirements appear in one module, while tracking submissions is in another. Additionally, tracking postmarket "where-can-I-ship?" elements is simple and straightforward with a SKU and country-code database.
  • Compliance is critical in the medical device world to ensure safety of users and patients. Compliance tracking allows companies to establish and maintain a validated state of control, while looking at efficient ways to stay ahead of changing regulations. Documentation Management allows organizations to prepare for future growth by reviewing content from multiple dossiers and leverage similarities of content increase speed to submission. In many situations’ documents are updated as products progress through lifecycle and by managing documentation change electronically increases efficiency. Utilizing reporting and statistics during business planning allows Regulatory Affair heads to show organizations the return on investment for regulatory departments. Reporting on the number of requests, submissions, approved/cleared submissions and timelines allows key performance indicators to be develop. Being able to report on the number of international requests allowed for the organization to enhance their approach on global expansion. Easy to implement and utilize, customization and collaboration with RegDesk team, tracking to allow for reporting to organizations allowing for visibility of global changes/updates.

Training

Documentation Not Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

RegAffairs AI
Portugal
regaffairsai.com

Company Information

RegDesk
Founded: 2014
United States
www.regdesk.co

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Categories

Categories

Integrations

Active Directory Not Supported
Arena Not Supported
Asana Not Supported
Boomi Not Supported
Dynamics 365 Customer Service Not Supported
Jira Not Supported
MuleSoft Anypoint Platform Not Supported
Okta Not Supported
OpenText AI Operations Management Not Supported
Oracle ADF Faces Not Supported
PTC Windchill Not Supported
Qualio Not Supported
Resource Management by Smartsheet Not Supported
SnapLogic Not Supported

Integrations

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