Orbit Solutions

Dynamic and integrated solutions for your global safety and risk management processes

Risk Management

Track global RMP documents, versions, and commitments

Implement international aRMMs and oversee effectiveness

Centralize monitoring of product risks

Manage periodicity and strategy for each product's safety surveillance

Manage signal detection activities, and Module IX assessment process

Manage benefit-risk meetings, strategies, and cross-functional collaboration

Manage PVA and SDEA content and commitments across global partnerships.

Automate partner document exchange based on your Safety Data Exchange and PV Agreements.

Manage detailed safety data line listing reconciliation

Track and maintain the PSMF centrally, manage local notifications and submissions

Harmonize global PSR schedule, manage generation and submission across portfolio

Guide your users through their work using streamlined and flexible workflow automation.

Let us show you how easy it can be to stay compliant, aligned, and inspection-ready—across every market you operate in.