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Regulatory Information Management

Manage regulatory content and processes to maximize revenue, efficiency and compliance

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Overview

A person reviewing regulatory information on a computer

Life Sciences companies must file regulatory submissions with regional health authorities to market new products and keep product registrations updated. The complex and evolving requirements force regulatory professionals to surface information and track projects across disparate, non-integrated technologies and data.

Regulatory Information Management solutions offer enterprise-wide regulatory content and process management that helps maximize revenue and minimize compliance costs without sacrificing quality.

Key benefits

Impact business and achieve better results.

  • Accelerate products to market

    Unify content management processes from planning to distribution to bring new products to markets more efficiently with faster time to approval.

  • Coordinate global product strategy

    Monitor end-to-end regulatory processes for proactive planning, authoring and execution using a single source of content with a high degree of quality and trust.

  • Demonstrate compliance

    Get a complete view of product-related interactions to easily surface information and demonstrate proper procedures to improve the outcomes of audits and inspections.

  • Optimize regulatory content

    Collaborate and reuse content across clinical, regulatory and quality domains to improve data quality and consistency within the global dossier.

Business impacts

  • Regulatory information management

    Life Sciences organizations must keep up with rapid regulatory changes. Regulated information is scattered across various systems, making it hard to adapt and slowing time to market. Unify regulatory information management to increase efficiencies.

  • Orchestrated submissions

    The volume and complexity of drug submissions continues to grow. With limited budgetary resources and staff, Regulatory Affairs struggles to keep up, hampering revenue growth. Streamline, automate and orchestrate regulatory activities.

  • Single source of truth

    In preparing a drug application, time is critical. Work processes cross multiple silos, leading to duplication and time wasted tracking information sources to verify accuracy. Maintain a single source of truth for fast, seamless collaboration.

  • Application completion

    Applications require content from various sources. Because information is gathered and consolidated from multiple tools and collaborators, it is easy to miss something and get rejected. Ensure submissions packages include all required elements.

  • Health authority requests

    Regulatory agencies require rapid responses to information requests. Delays stall the application process, leading to lost revenue and production holds. Leverage integrated document and communication records for quick responses.

Explore the components of the solution

Products

OpenText offers a bundled solution for improved Regulatory Information Management.

Professional Services

OpenText Consulting Services combines end-to-end solution implementation with comprehensive technology services to help improve systems.

Regulatory Information Management resources

A path to excellence in the global regulatory submissions process

Read the position paper

Gaining a complete view of regulatory activity

Read the position paper

OpenText Documentum for Submission Store and View

Read the overview

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