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Regulatory Compliance


We support complete coverage of the regulatory landscape.

Today, effective quality practices have involved formalizing a process after a quality issue has been found or raised. These issues come from the field, or from the development and launch process itself. Some solutions focus on the various tools for quality issue prevention, such as Quality Functional Deployment (QFD), Failure Mode and Effect Analysis (FMEA), etc. These disciplines and processes have been touted as the mechanism for issue prevention and quality improvement for years.

Key features & benefits
  • Complete coverage of the regulatory landscape; including product registration and tracking, submission management and document management.
  • Complete end-to-end UDI submission solution and global regulatory submission tracking all submissions and approvals for market approval or UDI submissions with capacity for thousands of products and hundreds of countries.
  • Provides a number of tools that are specifically designed to streamline the production of compliant regulatory dossiers.
  • Organizations get to regulatory approval faster with accurate submissions, which can also be reused for submissions to many different regulatory bodies.
  • Offering the richest and most powerful tools to enable the rapid creation, review and submission of regulatory dossiers.
  • Global Market Registration guides users in the collection of all relevant information required by the regulatory agency.
  • Templates streamline all data entries including D.I. attributes associated with the “unit of use” for each product. They must be managed across multi-level packaging hierarchy configurations to support enterprise use of this critical data.
  • A robust streamlined and traceable UDI submission management.
  • Streamline submission with developed templates for things such as; Workflow templates and submission templates (IDE,PMA,510K,CE).
  • Regulatory Submission Templates for consistent complete submissions and approvals in all countries.
  • Reduce time-to-market with complete UDI Management and Dossier Management from creation and beyond.
  • Manage Language requirement.