#FutureReadyHealthcare
German Biotech Partners with Indegene to Leverage Generative AI for HA Query and CMC Data Automation
The Need
The client was interested in identifying and prioritizing use cases in regulatory for designing Generative AI enabled solution along with their SMEs and technology teams
Indegene conducted multiple workshops with the client teams to identify potential opportunities and prioritizing the same on common parameters
Use cases prioritized included Health Authority (HA) Query Response automation and CMC data management
The Solution
The Indegene team collaborated with the client to build, test and implement Generative AI models for:
HA query automation ensuring compliance with varying regulations across different regions
Creation of a secure searchable repository for CMC data. The team ensured that the repository is secure, especially when dealing with sensitive data related to manufacturing and controls, while also making it easily accessible to authorized users
Outcomes
Indegene’s solution led to substantial efficiency gains and time savings across several areas. By implementing HA query automation and creating a searchable repository for CMC data, the customer significantly reduced the manual effort needed for data retrieval. This Generative AI powered solution significantly reduced the response time for submitting queries and data to health authorities, helping the customer meet deadlines consistently.
~76%
Reduction in time through CMC Q&A Bot
~$1.5Mn
Annual savings across CMC submissions
~ $5Mn
Overall savings through HAQ automation
~ 40%
Efficiency through HAQ automation
