Skip to main content

Vistaar case Study – 02

The Challenge

How can the data be analysed to prepare a regulatory strategy & risk analysis to make the changes in drug formulation? Consider the below-mentioned situations:

  • Markets impacted
  • Type of regulatory change
  • What documentation is required for submission package?
  • A timeframe for regulatory approval
  • When can the changes be implemented?
  • Commercial, Quality and Supply Chain impact

How did VISTAAR Help?

VISTAAR collates the information internally, identifies all the key attributes which impact the outcome of a regulatory decision. Performs data analysis and shares RI reports to the concerned stakeholders who are working on the project. These reports would help regulatory teams to take appropriate decisions which in turn would help in faster approvals.