Faster Market Access. High-Quality Submissions. That Changes Everything.

MasterControl Regulatory Excellence is a full-featured regulatory information management (RIM) solution that streamlines and accelerates global registrations and submissions processes so your products can reach more markets sooner.

Why does one of the most important steps your company will ever take feel so antiquated?

Years of R&D, thousands of trial hours and millions of dollars in funding – all in the pursuit of market clearance and a globally successful product. With so much on the line, you can’t afford to risk your future on manual, paper-based regulatory dossier compilation, agency submissions and global registrations.

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Make Your Dossier 100% Digital

When compiling and managing dossiers for agency submissions and global registrations, speed and accuracy can mean the difference between the success and failure of a regulated company. The MasterControl RIM solution integrates submissions and registrations management. It digitizes, automates and connects your regulatory management environment on a single platform to improve collaboration, increase accuracy and simplify template management.

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Improve Visibility and Alignment

Alleviating process bottlenecks, eliminating information blind spots and optimizing regulatory pathways are all vital to reaching new markets. MasterControl’s RIM system can help you gain real-time visibility into agency submissions and global product registrations processes across geographies, operational teams and in-market partners – all from one centralized solution.

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Harmonize Regulatory and Quality

Most of the documentation and data consumed and generated by regulatory teams is ultimately transferred to the quality management system, so a shared system of record just makes sense. The MasterControl Platform helps you seamlessly connect regulatory and quality management to streamline initial clearance and registrations while ensuring long-term compliance.

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    Regulatory Information Management (RIM)

    Accelerate the collection, harmonization and management of regulatory documentation and data from product development throughout the global submissions and product registrations life cycle, all in a centralized system.

  • Registrations Management

    Manage the organization and submission of dossiers, technical documents, global checklists templates, and tracking of product requirements for worldwide geographical locations while always keeping product registration data up- to- date.

  • Submissions Management

    Automate and accelerate eCTD submission documents, data, regulatory communications and publishing, and gain real-time visibility throughout the submission process, whether it is conducted in-house or via a partner.

Regulatory Excellence Suite

Let one of our experts show you how the MasterControl Regulatory Excellence solution fits your registrations and submissions management needs.

Request a Demo With an Expert

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  • Regulatory Information Management (RIM)
  • Registration Management
  • Submissions Management
  • Validation
  • MasterControl Platform
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Discover the MasterControl Platform

The MasterControl Platform is the foundation for complete product quality – connecting applications, documentation and data across your entire product development life cycle, from concept to commercialization.