Success Stories

Sandoz is using READY! to verify, validate, and submit XEVMPD product information to the EMA Gateway according to the Article 57 regulation.

Sandoz has successfully submitted more than 150,000 XEVPRM messages, so this makes it one of the largest installations in the pharmaceutical industry.

The solution has performed without a glitch from day one, including the latest implementation of the 3rd Acknowledgement.

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 would meet all of these requirements, and that could be implemented quickly, and according to the highest standards.

The project was finished highly successfully, on-budget, and in time.

Nanokinetik provided:
• 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

Billev Pharma has a large number of clients. They work hard to provide them with services in all Regulatory procedures, as well as in Pharmacovigilance.

Billev started using READY! in July 2011. Since then they have stored and managed all regulatory information in READY!.

Their environment is very complex to manage as they have to provide their clients with up-to-date information about the status of their medicinal products and activities.

READY! is helping them to manage information about medicinal products, tracking regulatory and pharmacovigilance activities, archiving electronic submissions, and managing documents. They also use READY! for time registering to be able to produce monthly reports for invoicing.

READY! is also being used to collect, validate, and submit XEVMPD product data to the EMA Gateway.

Billev Pharma needs to be at the forefront to provide the best regulatory services for their clients. This is why they are using READY!

For more about Billev Pharma go to: www.billevpharma.dk

Success Story: Billev Pharma ApS

"We have decided to implement READY! after careful analysis of the solution and the benefits of implementing it.

READY! has replaced our spreadsheets and is providing up-to-date information about all our medicinal products, documents, and on-going regulatory activities in the company.

READY! also integrated with EMC/Documentum, our document management system.

We are happy with the solution and the services Nanokinetik is providing to PharOS.”

Stella Koukaki
Managing Director/Pharmaceutical Oriented Services Ltd.

For more about PharOS go to: www.pharosgr.gr.

Dr. Reddy's has decided to implement “READY!” for the purposes of XEVMPD reporting to the EMA Gateway.

READY! has been successfully implemented within the agreed scope, time, and resources necessary for the implementation.

READY! is web-based and has enabled Dr. Reddy's to easily access, manage, and submit medicinal product information from various geographic locations.