Regulatory product overviews, fully sourced
Prepare structured product overviews from EMA, EUR-Lex, VIDAL and other trusted sources, with every claim linked back to the original reference.
Pharma REG gives Regulatory Affairs teams a cited baseline they can review, adapt, and reuse across portfolio monitoring, internal reviews, and regulatory documentation.
From product question to cited regulatory baseline
Pharma REG turns fragmented regulatory sources into a structured product overview your team can review, adapt, and reuse.
Search for a product, manufacturer, therapeutic area, or portfolio scope, such as EU-approved products only.
Pharma REG queries trusted regulatory and medical sources, for example EMA, EUR-Lex and VIDAL in real time and keeps the authoritative reference for each fact.
You receive a structured product overview with indications, authorization details, regulatory context, and source links, ready for your teams' review.
Pharma REGPart of Kirha Health
Pharma REG is the first Kirha Health agent for regulated life sciences workflows. It runs on our trusted data infrastructure, so teams can move faster without losing source traceability, reviewability, or control.
Learn about Kirha HealthRuns on a certified runtime: Kirha Infrastructure
Pharma REG runs on Kirha's runtime, designed for teams that need security, traceability, and control when working with regulated information.
It is built on audited and certified infrastructure for teams working with sensitive, regulated information.
Independently audited controls for security, availability, and confidentiality.
Certified information security management system.
Certified hosting for personal health data in France.
Designed to support EU data protection requirements.
Built for Regulatory Affairs teams
Start from a sourced baseline instead of rebuilding the same product overview manually.
Pharma REG helps your team prepare the first version of a product overview faster, while keeping every claim easy to verify.
Product overview preparation
Generate a structured first draft with indications, authorization status, regulatory history, product identifiers, and key source references.
Portfolio monitoring
Keep track of approved products, market status, and regulatory changes across trusted EU and national sources.
Competitor comparison
Compare products by indication, authorization route, therapeutic area, manufacturer, and market footprint.
Review and reuse
Give internal reviewers a source-linked overview they can check, correct, and adapt before using it in regulated work.
Built for teams working across fragmented data
Kirha is a killer tool for competitive analysis and market intelligence. It helps identify critical acquisitions candidates and conduct due diligence in record time.
Florent Jacques
— CEO at Meridian Partner
Our data sources are unstructured and fragmented across different data providers and internal databases. Analysts spend most of their time reconciliating data to extract valuable insights.
Why Kirha?
Kirha built for us an AI agent connected to all these data sources. It can answer top management questions during the week-end and boost our analysts productivity.