Expedite Premarket Approval With Efficient Document Submissions
Global Marketing Registration is a complete end-to-end UDI submission solution and global regulatory submission (PMA. 510K, CE.) software, tracking all submissions and approvals for market approval or UDI submissions with capacity for thousands of products and hundreds of countries. It enables users to efficiently submit documentation and improve collaboration in an effort to expedite the premarket approval from global regulatory authorities and automates the collection, editing, review, e-submission, change management, reporting and monitoring of UDI and market submissions. Global Market Registration facilitates communication between submission team members within the organization, and with agencies such as the U.S. Food and Drug Administration (FDA).
Global Market Registration is available on premise.
Key Features and Benefits:
Complete coverage of the regulatory landscape; including product registration and tracking, submission management and document management
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.