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.
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RegDesk Customer Reviews
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Would you Recommend to Others?1 2 3 4 5 6 7 8 9 10
RegDesk Pilot Implementation Successful
Date: Jan 25 2023SummaryThe 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.
PositiveThe 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.
NegativeSome 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.
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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 2023SummaryThis 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.PositiveComprehensive, user-friendly tool that consolidates all regulatory affairs processes in one place.
Excellent support provided by real experts that add value to our business.NegativeThere are no cons so far. The company was able to make small adaptations to our routine.
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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 2023SummaryWe have seen great benefits in using RegDesk, and it has been a pleasure collaborating with the RegDesk team.
PositiveRegDesk 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.
NegativeMy 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.
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Would you Recommend to Others?1 2 3 4 5 6 7 8 9 10
Superior Regulatory Affairs Software System
Date: Nov 20 2022SummaryOverall, 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.
PositiveCompliance 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.NegativeNo cons come to mind, RegDesk is exceptional in the collaboration with organizations.
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