Orbit Solutions
Dynamic and integrated solutions for your global safety and risk management processes
Risk Management
Plan, implement, and prove the effectiveness of risk minimization worldwide.
Risk Management Plans
Track global RMP documents, versions, and commitments
Additional Risk Minimization Measures
Implement international aRMMs and REMS and oversee their effectiveness
Post-Authorization Safety Studies
Track every PASS milestone and use the results to assess aRMM effectiveness against agreed success indicators
Risk Register
Centralize monitoring of product risks
Signals & Benefit-Risk
Run surveillance on schedule and move every signal through assessment to decision.
Signal Management
Manage signal detection activities and the Module IX assessment process
Surveillance Plan
Manage periodicity and strategy for each product's safety surveillance
Benefit-Risk Management
Manage benefit-risk meetings, strategies, and cross-functional collaboration
Safety Committee Management
Run DMC and DSMB operations with secure document handling and automated scheduling
Partners & Affiliates
Keep every partner obligation, exchange, and reconciliation visible in one place.
Reports & Compliance
Deliver periodic reports on time and keep inspection-ready records.
Aggregate Safety Reports
Harmonize the global PSR schedule and manage generation and submission across your portfolio
PV System Master File
Track and maintain the PSMF centrally, and manage local notifications and submissions
Electronic Communications Archive
Archive safety inbox email, chat, and social media communications
Across Every Solution
One validated platform underneath it all, with AI built in and room to track anything else you need.
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.
