Regulatory Excellence (Rx)

MasterControl Regulatory Excellence (Rx) is a full-featured regulatory information management (RIM) software solution designed for life sciences organizations. It streamlines and accelerates global registrations and submissions processes throughout the entire product lifecycle, helping regulated companies bring their products to more markets sooner and with greater confidence.

With years of R&D investment, extensive trial hours, and significant funding at stake, life sciences companies cannot afford to rely on manual, paper-based regulatory dossier compilation, agency submissions, and global registrations. MasterControl Rx replaces these outdated approaches with a unified, digital platform built to meet the demands of modern regulatory management.

100% Digital Regulatory Dossier Management

• Digitizes the entire process of compiling and managing dossiers for agency submissions and global registrations
• Integrates submissions and registrations management into a single, cohesive platform
• Automates and connects the regulatory management environment to improve collaboration and increase accuracy
• Simplifies template management across regulatory documentation
• Reduces the risk of errors associated with manual, paper-based processes

Improved Visibility and Alignment Across Global Operations

• Alleviates process bottlenecks that slow down regulatory pathways and market entry
• Eliminates information blind spots that can compromise submission accuracy and timelines
• Provides real-time visibility into agency submissions and global product registration processes
• Enables oversight across geographies, operational teams, and in-market partners from one centralized solution
• Optimizes regulatory pathways to support faster access to new markets

Harmonized Regulatory and Quality Management

• Connects regulatory and quality management on a shared system of record, reflecting the natural flow of documentation and data between these functions
• Streamlines initial market clearance and product registrations
• Ensures long-term compliance by maintaining alignment between regulatory and quality processes
• Supports seamless data transfer between regulatory teams and the quality management system (QMS)

The MasterControl Platform

• Serves as the foundation for complete product quality management across the full product development lifecycle
• Connects applications, documentation, and data from concept through commercialization
• Provides a unified environment that supports both regulatory excellence and broader quality management objectives

MasterControl Regulatory Excellence is purpose-built for life sciences organizations seeking to modernize their regulatory information management. By unifying submissions, registrations, and quality management on a single platform, it enables companies to reduce compliance risk, accelerate time to market, and maintain the accuracy required for successful global regulatory outcomes.