STAMFORD, CT—April 19, 2012—ArisGlobal, a leading provider of solutions to the life sciences industry, announced today successful medicinal product information submissions of Article 57 (2)-compliant messages and receipt of acknowledgements with EV Codes from EMA’s test gateway. This milestone marks the release and immediate availability of the company’s fully XEVMPD compliant solutions – Register 5.2.5 and agXchange RSM 5.4.
With the tight deadline for XEVMPD compliance looming (July 2, 2012), all product marketing authorization holders (MAH) that market their products in the European Union are working towards compliance before the deadline. In response to this shift in regulations, ArisGlobal is now offering customers product information management, tracking and submission technology able to automate the submission of the required data. In addition, the ArisGlobal solution provides a complete regulatory information management and tracking platform to centrally manage and seamlessly disseminate accurate and up-to-date regulatory information to all stakeholders.
The new offering enables customers to:
- Manage and automate the process of submission for all XEVMPD data
- Validate product information entered for compliance with all XEVMPD business rules according to the latest EMA guidelines
- Operate as a single tool for users to enter, submit, receive acknowledgements (e.g.: for successful submissions with Codes, errors or incomplete information) and view their status
- Manage and automatically merge product information documents that support product and substance information submissions
- Manage and track product information throughout a product’s life cycle
- Define high-level strategic and tactical plans for regulatory management
“We are very excited to be one of the first organizations able to submit and to receive successful XEVMPD acknowledgements for medicinal product information submissions,” said Wim Cypers, vice president of regulatory affairs with ArisGlobal. “Our customers will have the benefit of leveraging this technology to help automate their processes. This, along with ArisGlobal’s XEVMPD consulting, data migration, training and support services, offer the complete package to ensure compliance in time for the pending deadline.”
Register 5.2.5 and agXchange RSM 5.4 are available to customers immediately as a licensed on-premise offering or as a hosted solution via agOnDemand™, ArisGlobal’s comprehensive Software-as-a-Service (SaaS) delivery platform.
About ArisGlobal
ArisGlobal (www.arisglobal.com) is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. Hundreds of life science companies rely on ArisGlobal’s advanced solutions for maintaining regulatory compliance, workflow automation, improving operational efficiency and easily sharing information around the globe.
Contacts
Lorra Gosselin
ArisGlobal
+1.203.588.3000
lgosselin@arisglobal.com
