REGULATORY MANAGEMENT SOFTWARE REDUCES SUBMISSION TIME BY 80%
The only medical device RIM with integrated regulatory intelligence and AI automation.
TRUSTED BY LEADING COMPANIES
What is RegDesk?
Meeting various global rules is getting more complex, and changes are happening faster. To keep up, it’s crucial to invest in an all-in-one regulatory management software. RegDesk can help.
BENEFITS OF REGDESK'S RIM PLATFORM
Prepare international applications within 1 week instead of 4 months
Reduce response time to address international inquiries from 6-8 weeks to less than 20 hours
Avoid stress and nonconformities from a Health Agency audit
Why RegDesk RIMS
With RegDesk, Regulatory Management software, enter over 120 global markets before your competitors. We make following global and local laws easy for specialized pharma and medical device companies.
This is what makes us unique
Integrated Regulatory Intelligence
Create a quick and reliable regulatory strategy and manage potential risks proactively with integrated regulatory intelligence.
- Access up-to-date regulatory requirements for 120 markets
- Receive daily alerts on changing regulations
- Obtain timelines and costs per country
AI Submission Generator
Cut your preparation, publishing, and submission time for global applications to just hours with RegDesk’s AI technology
- Access country-specific, submission ready templates
- Prepare and publish global applications in formats acceptable by regional health agencies
- Leverage AI to autopopulate applications for subsequent countries
Tracking & Reporting
Monitor the entire lifecycle of your product and never again miss a renewal or ship a wrong product to a country.
- Track the status of registrations by product name and SKU
- Receive renewal notifications
- Generate reports on key performance indicators within seconds
Standards Management
Maintain compliance of standards and guidances worldwide and avoid non-conformities from audits.
- Search for international and country-specific standards and guidance documents
- Manage gap assessments on standards through integrated workflows
- Receive notifications on changing standards and guidance documents that affect your products
Change Assessment
Manage global impact of changes to a product faster and with ease through the Only Change Assessment Tool available with built-in regulatory intelligence.
- Understand the regulatory impact of changes to an existing product
- Generate report to see which products, countries, and SKUs will be impacted
- Manage change control workflows to collaborate with internal and external teams
AI Form Builder (GSPR, DoC, Requirements)
Reduce staff hours and errors by auto-generating GSPR, Declaration of Conformity (DoC), and Essential Requirements documents with RegDesk’s AI capability.
- Utilize AI and machine learning to auto-populate GSPR, DoC, and Essential Requirements
- Track which submission documents require change when a standard changes
- Automate bulk updates of the GSPR, DoC, and Essential requirements
Testimonials
Industries We Serve
Medical Device
RegDesk is the only Regulatory Management Software that has built-in Regulatory Intelligence for:
- Medical Devices
- In Vitro Diagnostics
- Software as a Medical Device
- Radiation Emitting
Pharmaceutical
Comprehensive Regulatory Intelligence for:
- Pharmaceuticals
- Biologics
- APIs
- Excipients
Сountries we serve
We can help you expand to 120+ markets in the world.
REGDESK REGULATORY ROUNDUP
Never miss a thing in the world of medical device regulatory compliance. The latest regulatory news and updates are always on our feed.
Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat...
Medical devices are highly regulated in the United States. Since U.S. regulatory compliance for MedTech is stringent and continuously changing, staying up-to-date on...
Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue...
