Compliance made simple in a complex regulatory world.

• Drug Safety People at CROs: Are you getting asked more often to run studies in countries you know little about? Get up-to-speed fast with iViReg.
• GVP Auditors: As the only GxP-validated regulatory intelligence tool with a simple Q&A format, this is a no-brainer for auditors.
• QPPVs: We're doing all the work you're doing - save your time and focus on more pressing drug safety issues.
• Regulatory Intelligence Specialists: iViReg + iViTracker will be a game-changer at your organization. Standardize on these tools and centralize your reg intel processes. Stop using excel and an offline repository of PV requirements - iViReg is your one-stop-shop and saves you from any compliance headaches.
• Reg Affairs / Clinical Operations: Whether marketing authorization is imminent, you're partnering with a distributor, or you're acquiring a new product, let iViReg guide you with ease. Google is not good enough - iViReg is the most reliable source of truth when it comes to PV requirements around the world.

We use a combination of three sources: 

1. Local Experts - our vast network of QPPVs are furnishing unpublished information, clarifying interpretations with regulators, and documenting all the evidence.
2. Website Searches - our reg intel team is using automatic and manual procedures to track relevant alerts on agency websites - we know where to look.
3. User Community - our network is incentivized to provide feedback when they have a different interpretation or understanding.

iViReg covers the entire lifecycle of medicinal products, including ICSR reporting, aggregate safety reports, local QPPV requirements, PSMF obligations, risk management, signal detection, safety communications, and post-authorization measures. iViTracker is a multi-purpose GxP compliance tool.

Current pharmacovigilance (GVP) applications include:

• Regulatory Intelligence (built-in to iViReg)
• RMP & aRMM Commitments
• Aggregate Report Tracking
• Signal Management
• PV Agreements Compliance Tracking
• ICSR Reconciliation Tracking
• Health Authority Requests
• Label Changes

When combined with iViReg Customer Question Builder, iViTracker can be repurposed to serve other GxPs including GMP, GLP, and GCP. It can also be be used to centralize regulatory, quality, marketing, and supply chain requirements. It can even be your repository for cosmetovigilance, nutrivigilance, materiovigilance, etc.

As a sponsor or Marketing Authorization Holder (MAH), you hold the ultimate accountability for pharmacovigilance (PV) compliance. While your CRO or QPPV provides valuable intelligence, direct access to iViReg gives you crucial advantages:

• Verify and Deep Dive: You can independently verify information from your partners, ensuring it aligns with your internal standards. Plus, iViReg offers granular detail with direct access to source documents and specific regulatory clauses, going beyond summarized reports.
• Real-Time & On-Demand: Regulations change fast. iViReg provides real-time updates and immediate access for ad-hoc queries, so you're never waiting for a scheduled report when you need answers now.
• Proactive Planning: Go beyond reacting. iViReg lets you proactively monitor for upcoming changes and explore "what if" scenarios for new products or markets, helping you anticipate compliance challenges and plan strategically.
• Audit-Ready Documentation: With iViReg's full audit trail and GxP-validated tracking, you can document your own intelligence gathering and decision-making, which is vital for audit preparedness and ensuring internal consistency across your teams.
• Cost-Effective Knowledge: Building internal PV regulatory knowledge with iViReg makes your team more self-sufficient, serves as a training resource, and can reduce reliance on costly CRO consulting time for routine inquiries.

iViReg...

• follows GxP so you have a full audit trail for every assessment, decision, and action (or inaction).
• covers over 100 countries which is more than any other system.
• is more cost-effective since it only focuses on pharmacovigilance.
• is more than a website crawler and uses PV experts to get the true interpretation.
• leverages the user community through a positive feedback loop so it's more dynamic.
• tracks and stores your assessments so you can build a custom repository specific to your products.

iViReg provides a centralized platform for pharmacovigilance regulatory intelligence in more than 100 countries, consolidating local and global regulatory requirements, expert insights, and verified regulatory documents. By offering structured data and continuous updates, iViReg helps pharmaceutical companies navigate complex compliance requirements efficiently.

Yes, iViReg enables users to compare PV regulatory intelligence across multiple countries, helping to navigate diverse compliance landscapes. However, access to comparison features starts when a user has more than one country included in their subscription package.

Each response in iViReg includes the latest verification date and provides a historical record of changes. Updates are systematically reviewed through continuous monitoring of national regulatory agencies and expert assessments, ensuring the most current and reliable information is available.