RegDesk Regulatory Compliance
Software

Regulatory Compliance Simplified

Eliminate the risk of lost revenue from missed deadlines, and prepare approval-ready international submissions in days instead of months. RegDesk simplifies compliance for specialized medical device and diagnostic companies globally.

Dashboard to track international registrations | RegDesk

Dashboard to track global registrations

What is RegDesk?

Complying with differing global regulations creates exponential complexity – and the pace of change continues to accelerate. To keep pace, investing in a holistic regulatory platform has become critical. RegDesk can help.

TRUSTED BY LEADING COMPANIES

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a blue and green logo for bausch + lomb
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BENEFITS OF THE REGDESK COMPLIANCE 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, expand to 120+ global markets ahead of your competitors. We make compliance with global and local laws and regulations easy for specialized pharma and medical device companies.

This is what makes us unique

Regulatory Intelligence

Develop fast and reliable regulatory strategy and manage potential vulnerabilities proactively through our comprehensive 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

Reduce your time to prepare, publish, and submit global applications from months to only a week using 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)

Decrease staff hours and errors by auto-generating GSPR, Declaration of Conformity (DoC), and Essential Requirements documents using 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 Graphic | RegDesk

Medical Device

Holistic RIM Solution with built-in Regulatory Intelligence for:

  • Medical Devices
  • In Vitro Diagnostics
  • Software as a Medical Device
  • Radiation Emitting
Pharmaceuticals Graphic | RegDesk

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.

A Guide to Navigating Regulatory Compliance for Medical Devices

by | Jun 14, 2024 | Medical Device Regulation Resources | 0 Comments

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 Device Regulations in the United States

by | Jun 14, 2024 | United States,USA | 0 Comments

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...

Leveraging RIMS for Global Market Access

Leveraging RIMS Platforms for Global Market Access

by | May 29, 2024 | HSA | 0 Comments

Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue...

FDA on clinical trials with decentralized elements (overview)

FDA Guidance on Clinical Trials with Decentralized Elements: Overview

by | Oct 28, 2024 | FDA,United States | 0 Comments

The article highlights the key points related to specific types of clinical trials.
FDA on clinical trials with decentralized elements (overview)

FDA Guidance on Clinical Trials with Decentralized Elements: Overview

by | Oct 25, 2024 | FDA,United States | 0 Comments

The article highlights the key points related to specific types of clinical trials.
FDA on clinical trials with decentralized elements (technologies and responsibilities)

FDA Guidance on Clinical Trials with Decentralized Elements: Technologies and Responsibilities

by | Oct 25, 2024 | FDA,United States | 0 Comments

The new article describes in detail specific technologies to be used for clinical trials with decentralized elements and also clarifies the roles and responsibilities of the parties involved.
FDA Guidance on Clinical Trials with Decentralized Elements: Administration and Oversight

FDA Guidance on Clinical Trials with Decentralized Elements: Administration and Oversight

by | Oct 25, 2024 | FDA,United States | 0 Comments

The new article provides additional clarifications regarding the oversight to be conducted by the authority when it comes to clinical trials with decentralized elements, and also highlights specific aspects related to the administration of products subject to investigation.
FDA on clinical trials with decentralized elements specific aspects

FDA Guidance on Clinical Trials with Decentralized Elements: Specific Aspects

by | Oct 25, 2024 | FDA,United States | 0 Comments

The new article outlines certain specific aspects related to the existing legal framework, such as packaging, shipping, safety monitoring, as well as the use of electronic systems.
FDA on PPI in TPLC-PPI role

FDA Draft Guidance on Patient Preference Information in the TPLC: PPI Role

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article emphasizes the important role of patient preference information.
FDA on PPI in TPLC (practical considerations)

FDA Draft Guidance on Patient Preference Information in the TPLC: Practical Considerations

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article pays additional attention to the specific practical considerations pertaining to the use of patient preference information.
FDA on PPI in TPLC (FDA feedback)

FDA Draft Guidance on Patient Preference Information in the TPLC: FDA Feedback

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article highlights the aspects related to obtaining feedback from the authority in order to ensure compliance with the relevant regulatory requirements.
FDA on PPI in TPLC (additional considerations)

FDA Draft Guidance on Patient Preference Information in the TPLC: Additional Considerations

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article is dedicated to additional considerations to be taken into account when using patient preference information associated with medical devices intended to be marketed and used in the US.