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Indegene helps a top-5 pharma scale dossier submissions by 50x
Challenges
Regulatory planning was heavily manual and fragmented.
Teams struggled with inconsistent interpretation of rules, limited visibility across submissions, and difficulty coordinating across markets.
There was also no intelligent way to bundle, adjust, or track submission plans. Making timelines longer and processes less efficient.
The Solution
Indegene deployed its NEXT Regulatory Submissions Planning platform to streamline and simplify the process.
Enabled smarter planning, tracking, and optimization of submissions
Introduced predictive analytics to recommend efficient bundling across markets
Standardized market rules through a just-in-time planning engine
Automated workflows and notifications to keep teams aligned and proactive
Outcomes
The client was able to scale submissions from 700 in 11 markets to 35,389 across 51 markets within a year.
They saved over 40,000 hours/year in regulatory operations, with projected savings of $1.03 million/year.
They could now bundle submissions to significantly reduce costs and prepare themselves to scale dossier submissions in future.
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Submissions across 157 markets in a year
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Hours/year saved in regulatory operations
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Gains in efficiency
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