Sandoz is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
Since 2013 Sandoz has seamlessly procesesed more than 500.000 XEVMPD messages for Article 57 reporting.
Installed and tested in only 3 months, READY! is seamlessly providing data validation, processing, Article 57 subbmissions and Acknowledges management in what is probably the largest Article 57 database installation in Europe.
About the project
The new regulation from the EMA regarding Article 57 and the mandatory submission of complex information about a large number of medicinal products has meant a dramatic shortage of implementation time.
Sandoz, one of the largest companies in the pharmaceutical industry, had an even greater challenge because they have such a vast product portfolio. Sandoz needed to integrate the solution with their existing systems – this is an additional challenge because out-of-the-box solutions had to meet their specific needs and IT environment.
The solution had to be a gateway solution with built-in validation prior to actual submission.
They had to choose the best system that meets all of these requirements, that could be implemented quickly, and according to the highest standards.
The project was finished highly successfully, on-budget, and on time.
- READY! software with a built-in ESTRI gateway
- On-time delivery
- Implementation advice
- Computer validation
- The capability to meet their quality objectives
- A dependable system that was up, and is still running without a hitch
- A system to submit a large number of messages
- Assistance 24/7