The Customer
The customer is a Japanese multinational biopharmaceutical company, with presence in more than 80 countries, and one of top 20 globally by revenue. The company is focused on metabolic disorders, gastroenterology, neurology, inflammation, and oncology.
Challenges
- Inability to keep pace with regulatory updates and actionable intelligence for local markets
- Lack of sufficient regulatory update analysis capabilities, to understand impact on existing portfolio
The Solution
Indegene deployed a knowledgeable team to monitor and track updates on new and upcoming regulations, registrations, clinical trials, supply chain, and so on.
We identified a comprehensive list of sources to aid periodical information gathering, and provided granular insights on local and global regulatory guidelines and updates, through email and newsletter communication. We also conducted an in-depth analysis of each regulatory update on client’s portfolio to enable timely and market intelligence and strategies.
Outcomes
Through our team’s expertise in information gathering, and analysis of regulatory updates, the client was able to overcome their inability to keep pace with local market regulations and act on it in a timely manner. Our portfolio impact assessment capabilities enabled the client to achieve >98% success rate in regulatory submissions both in terms of accuracy and compliance to regulatory requirements.
>99%
Accuracy in real-time regulatory updates
>98%
Submission success rate
100%
Regulatory compliance