How a Pharma Leader Managing 400+ Dossiers Across 15+ Countries Overcame Scalability Issues of a Legacy System with KnowledgeNET
About the Client
A leading pharmaceutical company with a dossier bank of over 400 products, operating in 15+ international markets, faced growing regulatory challenges. With an in-house regulatory team of 30+ experts, the company had been successfully managing ACTD, CTD, and country-specific dossier submissions. However, as they expanded into highly regulated markets like the EU, they needed a robust eCTD solution to streamline their submission process and maintain compliance with stringent guidelines.
The Hassle
The company partnered with Sarjen’s KnowledgeNET, known for its user-friendly eCTD software, to handle the complexities of their regulatory expansion. The first challenge was the initial submission, a crucial and often time-intensive phase for any pharmaceutical company. With KnowledgeNET’s intuitive interface and structured approach, the transition to eCTD became a straightforward, hassle-free process.
Edge Out with KnowledgeNET
For years, the company had focused on CTD submissions for ROW markets. As they aimed to enter regulated markets, they quickly realized that their existing manual processes and legacy systems were insufficient. The lack of an efficient, user-friendly eCTD software meant delays, compliance risks, and added operational costs. Seeking an affordable yet powerful solution, they explored multiple vendors and heard about Sarjen’s KnowledgeNET from industry peers who praised its ease of use and cost-effectiveness.
Tackling the Challenges
Unlike traditional implementations that take months, Sarjen’s KnowledgeNET’s eCTD solution was deployed seamlessly. The decision to adopt KnowledgeNET was driven by overwhelmingly positive feedback from existing users. The software’s intuitive design and automated workflows allowed the company’s regulatory team to master the system in under 30 minutes, significantly reducing training time and accelerating adoption. There were no major challenges during implementation—only the realization that the shift to eCTD could be far easier than expected.
The Impact
With KnowledgeNET’s eCTD software, the company saw immediate benefits: