The Customer
A leading global pharmaceutical company managing complex regulatory submissions across 170+ countries. Their teams handle large volumes of submissions, each governed by diverse and evolving market regulations.
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.
35,389+
Submissions across 157 markets in a year
42,888+
Hours/year saved in regulatory operations
40%
Gains in efficiency