Background

The last several years have seen an increasingly complex and demanding regulatory environment. For a company being non-compliant, failing an audit can have severe financial consequences (penalties, batch recalls). More importantly, a repeat of such recalls also will harm the company’s reputation, resulting in a market-reaching impact.

With every drug and medical device recall, life science companies become painfully aware of the increasing information gaps between regulatory affairs and other parts of the company. Pharmaceutical standards like ISO IDMP and device standards such as UDI are being driven by different geographies, creating a global compliance challenge for all life sciences companies. ArisGlobal’s LifeSphere Regulatory solutions bridge those gaps with powerful, market-proven solutions that are compliant with regulations of the US FDA and European Medicines Agency (EMA).

Regulatory Affairs

ArisGlobal understands that Regulatory Affairs (RA) departments face significant challenges to stay ahead of the ever-changing regulatory landscape. Lifesphere Regulatory solutions – SaaS-based regulatory information management system (RIMS) and compliance management (XEVMPD, IDMP) software –integrates compliance with business processes over the entire product management lifecycle. Our customers can feel assured that they are fully compliant with the latest product data submission standards and requirements and can fully handle the needs of their global and local regulatory teams.

Regulatory Information Management –LifeSphere RIMS™ is the innovative, SaaS-based regulatory information management system (RIMS) that leverages a process-based approach for tracking and managing all regulatory affairs (RA) submissions in a single solution. Based on 20 years of ArisGlobal experience in this domain and customer-defined industry best practices, it provides a proven approach for regulatory data management and is intuitive and easy to use  for even infrequent users. LifeSphere RIMS is configurable to meet specific organization requirements, and offers complete compliance with the looming ISO IDMP regulation and European extensions.

IDMP / Compliance Management– Companies can rely on LifeSphere IDMP™ to be the complete solution that handles all the technical, business and compliance challenges that organizations will confront on the road to IDMP compliance, including the currently mandatory XEVMPD submissions in Europe.  Available today, LifeSphere IDMP provides companies with an option to start collecting the IDMP information today not only in preparation for the mandatory IDMP compliance, but also as an opportunity to increase internal compliance between different departments, which can easily align across this international product definition.

Regulatory Submissions – Used by more than 20 companies, agXchange RSM™ is the solution that leverages ArisGlobal’s proven E2B data exchange system to provide a backbone for the electronic exchange of all regulatory data – XEVMPD, eCTD and UDI – between internal and external stakeholders. agXchange RSM is fully integrated with LifeSphere RIMS, ArisGlobal’s Cloud-based RIMS solution, yet can be integrated with any homegrown or third-party solution.