What is RegDesk?

RegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies.

• Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates.
• With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time.
• The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions.
• Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners.
• The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards.
• Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators.

To learn more about our offerings, please explore our website.

Pricing

Price Overview:
Contact us to learn more.
Free Version:
Free Version available.
Free Trial Offered?:
Yes

Integrations

No integrations listed.

Screenshots and Video

Company Facts

Company Name:
RegDesk
Date Founded:
2014
Company Location:
United States
Company Website:
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Product Details

Deployment
SaaS
Mac
Training Options
Documentation Hub
Online Training
Webinars
Support
Standard Support
24 Hour Support
Web-Based Support

Product Details

Target Company Sizes
201-500
501-1000
1001-5000
5001-10000
10001+
Target Organization Types
Mid Size Business
Enterprise
Supported Languages
English

RegDesk Categories and Features

RegDesk Customer Reviews

Write a Review
  • Reviewer Name: Shelly L.
    Position: Sr Manager, Corporate IT
    Has used product for: Less than 6 months
    Uses the product: Daily
    Org Size (# of Employees): 20,000 or More
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    RegDesk Pilot Implementation Successful

    Date: Jan 25 2023
    Summary

    The vendor is very willing to listen to our feedback and will work with us on enhancements going forward, which is refreshing for a software company.

    Positive

    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.

    Negative

    Some features are not available for general users, like importing data and reporting. The vendor's technical team was able to assist us with these requests.

    Read More...
  • Reviewer Name: ELAINE F.
    Position: Regulatory Affairs Director LATAM
    Has used product for: 1-2 Years
    Uses the product: Daily
    Org Size (# of Employees): 20,000 or More
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    A game change for our regulatory affairs departament

    Date: May 22 2023
    Summary

    This tool consolidates process and document management in a practical, intuitive and uncomplicated way. In addition to being a unique product on the market, the company offers highly efficient customer support, capable of understanding customer needs, always reflected in product improvements.
    RegDesk was a game change to our department. My team is happy to retire old excel spreadsheets.

    Positive

    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.

    Negative

    There are no cons so far. The company was able to make small adaptations to our routine.

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: VP Regulatory Affairs
    Has used product for: 1-2 Years
    Uses the product: Weekly
    Org Size (# of Employees): 500 - 999
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    RegDesk is an excellent Regulatory Information Management platform

    Date: Jan 23 2023
    Summary

    We have seen great benefits in using RegDesk, and it has been a pleasure collaborating with the RegDesk team.

    Positive

    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.

    Negative

    My firm's use case is slightly different than what most RegDesk customers would be looking for, however the team were highly responsive in clarifying our needs and then engaging with additional experts to add the regulatory intelligence information we had requested. This did take a little bit of time up front, but the RegDesk team were professional and very supportive.

    Read More...
  • Reviewer Name: Elizabeth H.
    Position: Senior Director, Regulatory Affairs
    Has used product for: 2+ Years
    Uses the product: Daily
    Org Size (# of Employees): 5,000 - 9,999
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Superior Regulatory Affairs Software System

    Date: Nov 20 2022
    Summary

    Overall, the experience with RegDesk and the team at RegDesk has been superior. Any question that our team had, RegDesk responded quickly and with potential solutions. RegDesk allowed our department to track, develop global strategies, work collaboratively with business partners globally, and expand market access of products. Prior to RegDesk many aspects were handled via email and implementing RegDesk allowed us to streamline, track, and gain efficiency in a global market.

    Positive

    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.

    Negative

    No cons come to mind, RegDesk is exceptional in the collaboration with organizations.

    Read More...
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