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.

Of course! Plans start at $14 per month per country for an individual user (clinical data only).

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 Local Experts - our vast network of QPPVs are furnishing unpublished information, clarifying interpretations with regulators, and documenting all the evidence.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.

Global Oversight and Awareness: regulatory intelligence touches every part of the PV workstream, from case management to signal detection and risk management, knowing what to do when falls on everyone and some things shouldn't be completely delegated.

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.

iViReg covers the entire lifecycle of medicinal products, from clinical trials to post-authorization requirements. Key areas include ICSR reporting, aggregate safety reports, local QPPV requirements, PSMF obligations, risk management, signal detection, safety communications, and post-authorization measures. The structured database ensures comprehensive regulatory intelligence for PV professionals.

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.

Yes, it is. iViReg is GxP-validated to comply with 21 CFR Part 11: Electronic Records; Electronic Signatures, and EudraLex Volume 4; Annex 11: Computerised Systems. iViReg supports audit trails that give you a response to any inspection request.