RIMS

RIMS- Regulatory Information Management System 

AmpleLogic RIMS (Regulatory Information Management System) is a web-based solution that helps life sciences companies to collaborate, manages global applications information data, Tracking the regulatory communications as well as customer communications and status of the regulatory activities that support entire product life cycle process.

 

ANDA Tracker

AmpleLogic ANDA tracker allows you to manage the complete Lifecycle of Applications filed against regulatory, starting from controlled correspondence to updating regulatory on the changes and events.

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DMF Tracker

AmpleLogic DMF tracker allows you to manage the complete Lifecycle of Applications filed against regulatory, starting from controlled correspondence to updating regulatory on the changes and events.

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Regulatory Information Management System activities in an organization start from the design of a drug to drug registration processes, to launch the product in the market place and that includes multiple departments in an organization to collect the regulatory data information includes design profile, concepts, technical information or specifications and if any prototypes. Presently these activities are managed through using the excel spreadsheets, paper records, and other legacy systems.

Due to the rapid changes in the regulations and data standards globally, making and managing the regulatory information management through a manual process has become a challenge for the pharmaceutical, Lifesciences and other related companies, etc. The regulatory standards made mandatory to adopt new technologies to plan for future requirements where all the documentation should be submitted through an electronic document management system

Key Capabilities of AmpleLogic Regulatory Information Management

  • Tracks the Customer Communications
  • Tracks the regulatory communications
  • Tracking of Approvals/rejection
  • Product Registration
  • Tracks all the QMS related activities
  • Identify the product registration details

Benefits of Regulatory Information Management

  • Streamlines the submission process
  • Improve collaboration & Accuracy
  • Ensure compliance risks
  • Eliminate the wastages
  • Reduce the costs
  • Increases the efficiency
  • Centralized Database can be accessed from regardless of location

AmpleLogic RIMS Software is designed in a way to automate the process, integrate with any existing or legacy system and increases the collaboration between department teams in an organization