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.
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.
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.
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.