Regulatory Information Management System (RIMS) is a life cycle process of drug (starting to end), from which organizations are effectively and efficiently developing and handling new and existing products information before, during and after drug registration.

Features of RIMS

Enhance the perfection and standard of pharma regulatory information
Plan, track and manage all regulatory activities, drug life cycle and submission operation
Maintaining an audit trail (versions & access control) as per the 21 CFR Part 11 compliance and also complying with regulatory submission standard
Effectively manage the post submission query raised by regulatory authority
Organize and trail regulatory events such as registration date, expiry date and other reminders
Unique place for search, store and manage all regulatory documents
Common processes for creating, organizing, sharing, archiving, authorizing, reviewing, approving and managing complete documents with minimum efforts
Effective Dashboard: Status of various tasks – their progress, updates, Graphical presentation of regulatory status, Effective reminders for events, Effective reminders for events
In-built conversion system

Benefits

  • Increase speed and quality of regulatory submission
  • Well organized pharma regulatory workflow
  • Effective tools to replace manual tracking processes
  • Reduce double data entry
  • Minimize inquiries raised from regulatory authorities
  • Access to all regulatory relevant product data and documentation
  • Easily excel to export actionable reports