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ZentraReg AI is an AI-powered regulatory intelligence platform that helps pharmaceutical professionals navigate ICH, FDA, and EMA guidelines. It provides instant, source-cited answers to complex regulatory questions and can validate uploaded documents against current compliance requirements.

Traditional regulatory databases require manual keyword searching through documents. AI regulatory intelligence understands the context and intent of your question, searches across thousands of guidelines simultaneously, cross-references multiple regulatory authorities, and delivers a synthesized, source-cited answer in seconds — dramatically reducing research time.

ZentraReg AI covers ICH (International Council for Harmonisation), FDA (U.S. Food and Drug Administration), and EMA (European Medicines Agency) guidelines and regulatory documents. This includes ICH Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) guidelines, along with thousands of FDA guidance documents and EMA scientific guidelines.

Yes, every answer from ZentraReg AI includes precise citations to the original guideline sections and documents. You can verify the source, read the full context, and reference the exact regulatory authority in your compliance documentation. This ensures transparency and builds trust in the AI-generated responses.

Yes, ZentraReg AI's document validation feature allows you to upload SOPs, protocols, submission drafts, and other regulatory documents. The AI cross-references them against current ICH, FDA, and EMA requirements, identifying potential compliance gaps and providing specific guideline references to help you address them.

Agentic RAG (Retrieval-Augmented Generation) is ZentraReg AI's advanced AI pipeline. Unlike simple retrieval, it uses a Plan → Act → Reflect → Refine cycle. The AI plans a search strategy, retrieves relevant information, reflects on whether the answer is comprehensive enough, and refines its search if gaps remain. This iterative process ensures more thorough and accurate regulatory answers.

Absolutely. ZentraReg AI is built with enterprise-grade security. All data is encrypted in transit and at rest. Your uploaded documents and regulatory queries are protected with strict access controls and are never shared with third parties or used for model training.

ZentraReg AI covers the full spectrum of ICH guidelines: Quality guidelines (Q1-Q14) covering drug substance and product quality, Safety guidelines (S1-S12) covering preclinical testing, Efficacy guidelines (E1-E20) covering clinical trials and design, and Multidisciplinary guidelines (M1-M14) covering cross-cutting topics like medical terminology and electronic standards.

ZentraReg AI is designed to augment, not replace, regulatory professionals. Its source-cited approach means every answer is verifiable against the original regulatory text. The AI excels at comprehensive cross-referencing across authorities, surfacing relevant guidelines that might be overlooked in manual searches, and synthesizing information from multiple sources into coherent answers.

Yes! ZentraReg AI offers a free tier so you can experience the platform's capabilities. Start asking regulatory questions immediately — no credit card required. Visit zentraregai.aezisai.com to get started.