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.
Impact business and achieve better results.
Unify content management processes from planning to distribution to bring new products to markets more efficiently with faster time to approval.
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.
Get a complete view of product-related interactions to easily surface information and demonstrate proper procedures to improve the outcomes of audits and inspections.
Collaborate and reuse content across clinical, regulatory and quality domains to improve data quality and consistency within the global dossier.
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.
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.
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.
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.
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.
OpenText offers a bundled solution for improved Regulatory Information Management:
OpenText Consulting Services combines end-to-end solution implementation with comprehensive technology services to help improve systems.