Orbit Solutions
Dynamic and integrated solutions for your global safety and risk management processes
Risk Management
Risk Management Plans
Track global RMP documents, versions, and commitments
Additional Risk Minimisation & REMS
Implement international aRMMs and oversee effectiveness
Risk Register
Centralize monitoring of product risks
Safety Surveillance and Benefit-Risk
Surveillance Schedule
Manage periodicity and strategy for each product's safety surveillance
Signal Management
Manage signal detection activities, and Module IX assessment process
Benefit-Risk Management
Manage benefit-risk meetings, strategies, and cross-functional collaboration
Managing partners and affiliates
Business Partner and PV Agreements
Manage PVA and SDEA content and commitments across global partnerships.
Document Exchange
Automate partner document exchange based on your Safety Data Exchange and PV Agreements.
Safety Data Reconcilation
Manage detailed safety data line listing reconciliation
Reports and Submissions
PV System Master File
Track and maintain the PSMF centrally, manage local notifications and submissions
Periodic Reports
Harmonize global PSR schedule, manage generation and submission across portfolio
Ad Hoc reports and commitments
Guide your users through their work using streamlined and flexible workflow automation.
Ready to learn more?
Let us show you how easy it can be to stay compliant, aligned, and inspection-ready—across every market you operate in.