One platform to manage and track your global GvP processes

“Orbit is a straightforward and dependable way to manage what are often complicated logistics around compliance obligations.” - Top 10 Pharma Client

Global & Local RMPs - GVP V

Distribute core Risk Management Plan information and track all local RMP and REMS commitments

Signal Management - GVP IX

Compliance from review cycles through document updates

Risk Minimization - GVP XVI

Distribute Additional Risk Minimization Measures (aRMMs) to affiliates, track local implementation and spot deviations

Label changes

End-to-end tracking for Reference Safety Information changes, local safety variations and deviations

Aggregate Reports - GVP VII

Capture Data, Generate Documents and Track Quality Control with audit trail

PVAs - GVP I

Schedule and track compliance to your Pharmacovigilance Agreements with partners and vendors

PSMF - GVP II

Pharmacovigilance System Master File compliance for global and local tracking

Health Authority Requests

Track Health Authority (HA) Requests to manage your team and generate responses

Add. Monitoring - GVP X

Track medicines identified by a Health Authority for additional monitoring

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Global, validated, extensible tracking with audit trail

“Our users have expressed a high level of comfort using the modules and the general feedback is that the system is easy to learn and use.” - Pharma Client

Global medicines view

Get a global view of a drug and the activities around it, from RMPs to label changes.

Customizeable templates

Create and track new kinds of internal compliance measures, just point-and-click.

Document collaboration

Collaborate with your global organization in one cloud-based compliance solution.
workflow

Powered by workflow

Advanced task management with an integrated enterprise Workflow engine.

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