Enhancing Life Sciences Systems, Productivity and Compliance


  Contact : info@ongoose.com

Regulatory activity becomes the key trigger for all impacted changes between departments, deadlines and multiple markets on a global scale. eRA is a solution which comes with a centralized Regulatory Information Management System (RIMS) that enables you to proficiently manage your master data well and track regulated data, actions, operations, submissions and commitments.

  FEATURES

  • Maintains authoritative database of all products worldwide
  • Enables the review and approval of all submissions
  • Tracks all supporting documents required for eCTD, EVMP and Dossier submissions
  • Supports national, centralized, and mutual recognition submission procedures
  • Maintains complete registration history with version control
  • Integrates with Documentum, SAP and other systems
  • Tracks licensing agreements and cooperative ventures with other organizations (in-license and out-license agreements)
  • Manages queries and deficiencies with responsible departments
  • Provides alerts and notifications

  BENEFITS

  • Timely submissions and renewals
  • Single place of Tracking
  • Single source of information for your regulatory product maintenance
  • Reduce time and effort creating product documentation and regulatory submissions