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pharmacovigilance regulatory intelligence.
iViReg empowers the pharmacovigilance community by leveraging a global network of experts, offering local regulatory interpretations, support documentation, and reference links, all conveniently translated into English.
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iViReg Business Owner at iVigee, Paulina, explains a few cool features here...
An invaluable tool for quick comparisons and tracking changes
For me, iViReg is an outstanding tool because, so far, it has provided PV requirements from every country I needed that and for any area. It allows me to compare requirements across multiple countries and topics at once and at lightning speed. Additionally, it enables me to search for changes that have occurred in a specific country over a certain period, which is incredibly helpful for supporting colleagues who are returning after a longer absence or transitioning to a new role.
A trusted partner combining accuracy and expert support
As a Project Manager in Pharmacovigilance, my priority is providing our clients with easy and reliable solutions for global compliance. iViReg provides accurate, up-to-date compliance data in just a few clicks. What truly sets iViReg apart is not just its user-friendly design but also the expert team behind it. Whenever we need additional clarification or guidance, the iViReg team is there to support us. This combination of a powerful platform and expert assistance allows our clients to feel secure, knowing their compliance needs are handled effectively, while we can focus on managing other priorities with peace of mind.
A trusted tool for streamlining assessments and ensuring compliance
iViReg has become an essential tool for my daily work. iViReg not only compiles global regulations but also provides historical context and original source links. GxP validation gives me complete confidence, and the iViTracker feature helps streamline impact assessments and implementation, which is invaluable during audits. Plus, the iViReg team is always quick to respond whenever I have questions. It is a tool I trust and rely on every day.
Pharmacovigilance (PV) ensures the safety of medicines by monitoring and assessing adverse drug reactions (ADRs) as well as other safety measures throughout the product lifecycle. This includes activities during clinical trials, marketing authorization, and post-authorization phases, covering risk management, periodic safety updates, signal detection, and regulatory compliance. Regulatory intelligence in PV helps organizations stay compliant with evolving requirements, enabling them to understand and implement national and global safety regulations effectively.
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.
iViReg gathers intelligence through a network of over 100 local PV experts, ensuring a deep understanding of national regulations and real-world implementation. All collected data undergoes rigorous quality control by iVigee’s internal PV Regulatory Intelligence team, who verify source documents and cross-check information against primary regulatory evidence. Additionally, iViReg weekly monitors regulatory agencies and international bodies to ensure the latest updates are incorporated.
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.
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.
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.
Yes! 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.
Yes! iViReg provides access to local PV regulations in their original language, either as downloadable documents or through direct reference links. Additionally, an increasing number of these documents are translated into English to support global accessibility.
Yes! iViReg allows users to download or print country-specific regulatory intelligence. Information can be exported in Excel (.xlsx) format for analysis or saved as a PDF for documentation and compliance purposes.
This feature provides exclusive insights from local experts and Competent Authorities, offering deeper regulatory understanding beyond publicly available sources.
PV regulatory intelligence ensures organizations involved in medicinal product development and safety remain informed about local ADR reporting requirements, including what must be reported, timelines, submission formats, and language specifications. This knowledge is essential for maintaining compliance with national and regional regulations.
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