Leading the Way with Comprehensive Regulatory Affairs Information Management System

Aris Global understands that Regulatory Affairs departments face significant challenges to stay ahead of the ever-changing regulatory landscape. Our Total Regulatory suite of regulatory information management (RIMS) and compliance management software, integrates compliance with business processes over the entire product management lifecycle and product data submission management.

With every drug and medical device recall, life science companies are becoming painfully aware of the increasing information gaps between regulatory affairs and other parts of the company. Total Regulatory solutions bridge those gaps with powerful, market-proven solutions that are compliant with regulations of the US FDA, and European Medicines Agency (EMA).

Used by the world's leading pharmaceutical companies, Total Regultory compliance solutions provide the assurance that regulatory affairs is successfully managing and tracking all registrations, re-registrations, updates, EVMPD submissions, eCTD related documents, questions/commitments and change requests in a consistent and compliance manner.

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The market-leading regulatory and compliance solution for centrally managing and tracking global product registrations a product's entire lifecycle.

agXchange RSM

This market-leading regulatory submissions application enables efficient submission of medicinal product dictionary related data as required by the EMA under the new EVMPD regulation. It can be easily extended to support the electronic submission of other regulatory data including SPL, PIM and eCTD documents.

A4L

i4i is an XML-based SPL (Structured Product Labeling) solution that addresses all authoring and lifecycle management of e-label production.

In today's global market, Total Regulatory helps life science companies aggressively seek to mitigate risk, lower their research and development costs, and secure their manufacturing and product supply chains.

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