An AI-powered platform that transforms how pharmaceutical professionals navigate regulatory complexity — from ICH and FDA to EMA guidelines.
According to ICH Q3D(R2), elemental impurities in oral drug products must be evaluated against Permitted Daily Exposure (PDE) limits. The key requirements include...
Every feature is designed to accelerate regulatory decision-making while ensuring the highest standards of accuracy and compliance.
Unlike simple keyword search, our AI uses a Plan → Act → Reflect → Refine cycle to deeply analyze your questions and iteratively retrieve the most relevant regulatory information.
Advanced AI ArchitectureUpload SOPs, protocols, or submission drafts and let AI cross-reference them against current ICH, FDA, and EMA requirements — identifying gaps and suggesting corrections.
Automated ValidationGo beyond keyword matching. Our semantic search understands regulatory context and intent, finding relevant guidelines even when exact terminology differs across authorities.
Context-Aware SearchAutomatically identify overlapping requirements across ICH, FDA, and EMA guidelines — ensuring your compliance strategy covers all relevant authorities simultaneously.
Multi-Authority IntelligenceZentraReg AI maintains a comprehensive, continuously updated database of regulatory guidelines from the world's leading pharmaceutical authorities.
Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) guidelines covering drug development standards.
FDA guidance documents covering CDER, CBER, device regulations, CMC requirements, and clinical trial standards.
EMA scientific guidelines, regulatory procedural guidance, and CHMP opinions for European market authorization.