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Large biopharmaceutical enterprise streamlines HA query management ​

The Customer

A leading global biopharmaceutical company focused on human healthcare and research with a large product portfolio (innovator, prescription, over the counter, etc.) covering major therapy areas including vaccines.


  • Multiple queries from Health Authority (HA) across submissions; leading to significant approval delays ​

    HA query addressal was a reactive process based on HA’s response to submissions​​

The Solution

Indegene created a searchable database of historical HA queries tagged against taxonomies. Client was also able to tag HA responses against corresponding queries. We used predictive modeling in the engine to predict queries based on multiple parameters such as HA, therapy area, document type and others.

Client was able to prioritize queries on probability/confidence scores, based on algorithms from historical data. We also used historical data to suggest responses and actionable insights specifically around additional documentation required for potential queries.


Indegene was able to streamline management of HA queries, for the client, across submissions, enabling faster and successful submissions

Client teams were able to leverage the AI based solution to proactively prepare for potential HA queries on their submissions and reduce the number of iterations before receiving HA approvals


Iterations for successful submissions


Faster HA query and response search


Faster HA query responses