RegDesk

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.

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

Overall: 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.

Pros: 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.

Cons: 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.

Overall: 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.

Pros: 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.

Cons: 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.

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

Pros: 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.

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

Overall: 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.