Regulatory Affairs

going beyond compliance

The life sciences and pharmaceutical industries are perhaps the most highly regulated in the world, and the financial and resource investments required to bring products to market have increased significantly.

As companies seek to secure their product pipeline and supply chain, the need for a single, authoritative view of global product information has never been more critical. That single,

holistic view is only possible when regulatory affairs, safety, manufacturing and other critical areas of the company are monitoring, reporting to, reporting from, tracking and making decisions based on the same product content.

Yet with every drug and medical device recall and market withdrawal, companies are becoming painfully aware of increasing information gaps between regulatory affairs and other areas of the company such as manufacturing and marketing.

Leading the Way in Regulatory Information Software

Aris Global^® has developed regulatory information software that integrates compliance with business processes and regulatory activities. Used by many of the world's leading pharmaceutical companies, these pharmaceutical regulatory compliance solutions provide the assurance that regulatory affairs is successfully managing registration tracking, registration updates, questions/commitments and change request management.

Register™ - The market-leading solution for centrally managing products and tracking global registrations across each product's entire lifecycle.

agXchange RSM™ - The regulatory submission management module of the agXchange™ modular gateway for extended electronic exchange enables customers to update the EVMPD product data as requested by the EMEA.

A4L™ - i4i's XML-based solution that addresses all authoring and lifecycle management aspects of e-label production.