It's in Orbit.

The validated PV system of record for safety ecosystem governance, global oversight, and inspection readiness.

Why Orbit

Governance and global oversight for your entire safety system

Orbit's proven trackers manage your core PV processes, from RMPs and aRMMs to signals, aggregate reports, PV agreements and the PSMF. Orbit also integrates with your safety database, RIMS, DMS and affiliate tools, extending that oversight to the work those systems hold, so PV leaders get one validated record of every commitment, owner, deadline and piece of evidence.

Safety ecosystem governance

One governance layer across your safety stack. Orbit tracks your core PV processes directly and connects to the systems you already run, so obligations don't fall through the seams between teams, partners and tools.

Global oversight

Every PV process, product and market in one view. Global commitments flow out to affiliates and partners, and their status flows back, so the QPPV and PV leadership can see what's on track and what's at risk, right now.

Inspection readiness

Readiness as a standing state, not a last-minute scramble. Every item has a named owner and due date, and decisions and evidence are recorded as the work happens, with a full audit trail ready on day one.

100% of surveyed local PV staff found risk management information easy to access in Orbit Ingate et al., Therapeutic Innovation & Regulatory Science, 2025

Validated SaaS GAMP 5 · 21 CFR Part 11 & EU Annex 11 · SOC 2 Type II · Hosted on AWS

See how Orbit works Read the white paper: One Record, Full Oversight

Connected Patient Safety

Orbit is a strategic platform for patient safety, helping small, medium, and large biopharma companies scale their safety operations across global markets.

Risk Management and Minimization

Track global RMP commitments and support local Additional Risk Minimization Measure implementation.

Safety Data Exchange & PV Agreements

Manage PVA and SDEA content and commitments to gain oversight across global partnerships.

Signal and Surveillance Management

Module IX signal management from strategy through detection activities, signal assessment and tracking.

Aggregate Safety Reporting

Manage global Aggregate Safety Report schedule, generation, contributions and status across all products.

Cross-functional tracking solutions

Orbit's cross-functional trackers connect PV teams, breaking down data siloes and supporting consistency across the organization.

Document Exchange

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

Safety Commitments

Track Safety Commitments and Health Authority Requests across Regulatory and PV functions.

See the webinar →

Areas for Close Monitoring

Manage lists of safety concerns and close monitoring events with structured MedDRA query strategies.

A strategic platform

Orbit offers the tools your team needs to deliver value across pharmacovigilance, safety, and risk management functional areas.

Workflow Management

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

Dashboards and Reports

Simplified reporting on all system data in real-time dashboards and automated snapshot reports.

Visibility across processes

Orbit is an interconnected system, allowing you to connect related business processes or use them as modular solutions.

Automated Notifications

Configurable notifications keep your teams aware of their timelines, responsibilities without manual reminders.

AI Enabled Processes and Oversight

Use AI to gain better insights into your data, documents, and process indicators.

Advanced Configurations

We bring the software, you bring your SOP's: Orbit is fully configurable to your process and requirements.

The Orbit Webinar Series

Browse upcoming and on-demand content from the Orbit webinar series.

View all

Simplify & Harmonize Pharmacovigilance Aggregate Safety Reports

Pharmacovigilance teams face increasing challenges in managing aggregate safety reports across multiple regulatory frameworks. Discover how Orbit streamlines global pharmacovigilance compliance.

Additional RMMs, managed: Module XVI Compliance with Orbit

In an evolving regulatory landscape, pharmaceutical companies must implement effective Additional Risk Minimization Measures (aRMMs) to ensure patient safety and meet compliance requirements.

Global Additional Risk Minimization Measure Implementation: Enable Harmonization, Ensure Compliance

How do you and your teams effectively manage the increasingly complex implementation of additional Risk Minimization Measures (aRMMs) in the pharmaceutical industry?

Never Miss a Safety-Related Deadline: Automate the Tasking and Tracking of All Your Safety Commitments

Teams often grapple with information overload, struggle to maintain effective oversight, and face collaboration hurdles.

Integration and Automation: Leverage Key System Data and Supercharge Your PVRM Operations

Uncover the transformative power of Orbit's seamless integration capabilities. Experience automated updates to regulatory information and due dates, guaranteeing foolproof compliance.

Streamlining Local Safety Action Oversight: Automating Global-to-Local Communications, Commitments Tracking and Full Lifecycle Management

Discover how Orbit automates global-to-local safety communications, tracks commitments, and ensures comprehensive lifecycle management for safety actions.

Thoughts & messages from the Orbit Team

View all

Orbit Team Contributes to New Publication on Advancing Pharmacovigilance Practices

We're proud to share that Orbit team members Kevin Fetterman and Christopher Long have co-authored a newly published article in Therapeutic Innovation & Regulatory Science.

From Blind Spots to Full Visibility: Rethinking Oversight in PSMF Management

Why QPPVs and global PV leads need better analytics—and how to get them. For pharmacovigilance leaders, managing the Pharmacovigilance System Master File (PSMF) isn't just a documentation exercise—it's a regulatory responsibility.

Risk Minimization in the age of AI: preparing for the future of patient safety

Pharmacovigilance is rapidly evolving, driven by technological advancements that transform how pharmaceutical companies monitor, detect, and manage the risks associated with marketed products.

Learn why leading organizations choose Orbit.

Request a Demo Contact Us