Regulatory Tracking & Management

Pharmaceutical and Biotech companies can control regulatory affairs and operations globally, fostering compliance and improving regulatory submission efficiency

Regulatory requirements can be burdensome even the most dedicated and process-driven organizations. Managing  information and content from CRO’s, CMO’s and other partners is complex. The key is to effectively manage both the changes and the flow of material from various partners and sites. Without effective management, regulatory hurdles will quickly clog the new product pipeline.

Regulatory Tracking & Management enables life science companies to take control of quality and regulatory operations, fostering compliance and improving operational performance globally. Designed for the highly-regulated life sciences industry, the solution improves regulatory submission assembly, review and approval processes through end-to-end document and workflow management within regulatory guidances.  This reduces costs, improves efficiencies and accelerates submissions of  regulatory applications. Higher quality submissions with less iterations reduces content review and approval cycles by up to 40% and improves success rates. Regulatory Tracking & Management is a flexible 'out of the box' system, complete with validation test scripts, which accelerates deployments and reduces IT costs.