Driven by a growing interest amongst regulators, consumers and the medical community, product safety and pharmacological risk management has risen dramatically in both importance and visibility over recent years.

In order to meet the increasingly complex and diverse global regulatory requirements, GSTi USA has a comprehensive suite of integrated software solutions strategy  that enable all life sciences organizations, regardless of status or size, to implement effective domestic and global pharmacological risk management programs.

The life sciences and pharmaceutical industries are perhaps the most highly regulated in the world, and it's constantly changing. Regulatory authorities are unifying their submissions structures to improve the collection, scrutiny and storage of data. Initiatives such as SPL/PIM, eCTD, ICH M5 and EVMPD are forcing companies to implement systems to maintain compliance, while information concerning the derivations of every pharmaceutical product as it is marketed, maintained and actively enhanced through its life cycle must be kept up-to-date.

To ensure life sciences and pharmaceutical regulatory compliance on a global basis, GSTi USA is in the process of developing the  regulatory information software that integrates compliance with business processes and regulatory activities. Supporting all major regulatory initiatives, including the EVPMD we provide extremely versatile software that supports registration tracking, registration updates, questions/commitments and change request management