RegDesk

RegDesk is a Regulatory Information Management System (RIMS) developed by RegDesk, Inc. The software is designed to provide regulatory intelligence and support for medical device and pharmaceutical companies. It offers a comprehensive platform for managing global applications, regulatory submissions, and compliance with regulatory standards and requirements. With real-time alerts on regulatory changes, RegDesk helps users stay informed and take timely action. The software is suitable for companies of all sizes, from small startups to large multinational corporations. It is utilized by medical device manufacturers, pharmaceutical companies, regulatory affairs professionals, quality assurance/quality control professionals, and compliance officers.

Key Features

Comprehensive Regulatory Intelligence: RegDesk provides regulatory intelligence for over 120 markets worldwide, covering medical device and pharmaceutical regulations. It keeps users up-to-date with the latest regulatory changes.

Centralized Regulatory Information Management: RegDesk offers a holistic Regulatory Information Management System. It helps manage global applications and regulatory submissions, facilitating compliance with regulatory standards and requirements.

Real-time Regulatory Alerts: RegDesk provides real-time alerts on regulatory changes. It alerts users to new regulations, guidelines, and updates, helping them stay informed and take timely action.

Global Expansion Support: RegDesk assists with the global expansion of medical device and pharmaceutical companies. It provides information on regulatory requirements in different markets, helping navigate the complexities of international regulatory compliance.

Access to Compliance Experts: RegDesk offers access to a network of over 4000 compliance experts worldwide. Users can obtain verification on critical regulatory questions and receive expert guidance and support on regulatory matters.

Clinical Trials Management: RegDesk provides a comprehensive platform for managing clinical trials of medical devices and performance studies for IVD medical devices. It ensures compliance with the legal framework and ethical standards, streamlining the process with clear guidelines and procedures.

Ethics Committee Management: RegDesk facilitates the composition and function of ethics committees involved in clinical trials. It streamlines submission requirements and ensures compliance with ethical guidelines, simplifying the authorization process.

Stakeholder Roles and Obligations: RegDesk outlines the roles and obligations of stakeholders in clinical investigations. It provides clear guidelines for researchers, sponsors, ethics committees, and regulatory authorities, promoting efficient collaboration.

Monitoring and Reporting: RegDesk enables efficient monitoring and reporting on clinical research. It tracks progress and generates reports on key performance indicators, ensuring compliance with reporting requirements.

Compliance with Legal Requirements: RegDesk ensures compliance with legal requirements for clinical investigations. It provides access to relevant regulations and guidelines, helping researchers stay up-to-date and navigate the complex regulatory landscape.