Regulatory Information Management




Microsoft 365, SharePoint, Azure Cloud


The customer is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of medicines.

Business Challenge

A life sciences company partners with WinWire to address regulatory compliance challenges.

The company is required to track and meet compliance regulations for its products and take a new drug to the market faster.

The company was looking to build a unified Regulatory Information Management (RIM) system which can make regulatory compliance process more effective and efficient.

The significant impediments of Regulatory Affairs organizations included

  • No holistic view of the regulatory process from clinical trial to approval
  • Data silos across multiple systems and countries created lack of visibility
  • Dependency on manual processes and excel files – inefficient, slow & error prone
  • Changing the global submission tracking and license management mechanism
  • No visibility into how data is tracked – e.g. submission timelines, expiry dates for licenses
  • Need a submission tracking platform that provides real time updates on the product portfolio and pipeline

WinWire Solution

WinWire helped the life science company develop a robust Regulatory Information Management (RIM) solution that simplified regulatory submission tracking process.

RIM solution stitches the digital fabric through “systems of intelligence” by unifying all submission data from legacy systems and multiple data sources enabling organizations to be compliant and bring a new drug to the market in lesser time.

WinWire removed the data silos by bringing together enterprise-wide data to create a single source of information and created an intuitive platform for use across multiple global departments. RIM solution enables submission planning and tracking with license lifecycle management.

This has provided the senior leadership a bird’s eye view of all the product pipeline across the globe which helps them plan their resources/efforts more efficiently and effectively.

Business Value

  • Decreased legacy system maintenance cost
  • Maximizes revenue and minimize compliance and quality costs
  • Data quality improvement

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