Revolutionizing Pharma with AI

iPharmaAI is transforming pharmaceutical R&D by integrating AI to optimize drug discovery, reduce regulatory risks, and speed up time-to-market.

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Artificial Intelligence (AI) LLM based Database

Technical Tools Suite

A powerful set of digital tools built with AI & automation to streamline regulatory operations. Includes validation checklists, compliance heatmaps, and smart document generators. These tools enhance efficiency, minimize manual work, and ensure your team stays audit-ready at all times.

483 SaaS + AI Platform

Our cloud-based SaaS product offers access to 9,000+ 483s powered by LLMs. Use AI-driven search, root cause detection, and auto-PaCA generation to explore FDA data. Get real-time summaries and export ready-to-use reports, helping teams stay compliant and audit-ready with speed and precision.

Warning Letter Insights

A curated database of 4,000+ FDA warning letters analyzed by AI. Easily explore trends, repeated deficiencies, and company-specific issues. Built-in analytics and filters help track regulatory focus shifts, enabling faster remediation strategies and reducing compliance risks significantly.

How our 483 AI system will help you

At iPharmaAI, we have implemented advanced AI techniques, including Large Language Models (LLMs), to enhance the intelligence of our 483 FDA Observations Database. By leveraging LLMs, we have developed a smart chatbot trained specifically on FDA regulatory data, enabling users to interact with the system in natural language. This chatbot not only retrieves relevant observations but also summarizes complex inspection data, identifies potential root causes, and suggests preventive and corrective actions (PaCAs) based on historical insights and compliance patterns. The integration of AI-driven summarization and contextual analysis helps regulatory teams better understand deficiencies, accelerate decision-making, and proactively mitigate compliance risks with actionable, data-backed solutions.

Our Expert Guided Technical Tools

ANDA Review Checklists and Upper Management Review Checklists

The ANDA review checklist database covers 11+ dosage forms, ensuring accurate completion of key sections like CMC, Bioequivalence, and Labeling. By identifying gaps early, it minimizes deficiencies, prevents RTR classification, and enhances review efficiency. This structured approach streamlines high-level reviews, reducing errors and speeding up approvals.

White Paper (Strategic Paper)

The white paper offers a structured format for scientific strategy, covering product inception to submission. It consolidates all strategic information into one organized format, ensuring the right approach from development to filing. It also gives the clear guidance on product specific guidance study which to be conducted. By addressing key requirements early, it minimizes rework and deficiencies, increasing the chances of 1st cycle approval with a high-quality filing.

Controlled Correspondence

The CC database offers multiple template options for various dosage forms and topics, ensuring flexibility. It also includes a Do’s and Don’ts guide to maintain accuracy. Ready-made information enables efficient CC creation, with downloadable Word templates for easy customization. This saves time and increases the chances of straight FDA acceptance as well as get positive FDA response for further activities .

DMF Checklist

This comprehensive guide covers all essential requirements, ensuring streamlined approval through Complete Assessment (CA) and Scientific Assessment (SA). Regular utilization enhances submission quality and compliance while helping identify potential gaps early to minimize rework. By facilitating an efficient regulatory review process, it ultimately supports faster approvals. This checklist can be utilized for own DMF as well as other Vendor’s DMF for Open part.

API/FP Validation Checklist

This validation framework ensures compliance with current regulatory requirements for drug substances and products. By addressing validation gaps, it strengthens quality systems, reduces deficiencies, and lowers the risk of a complete response. It also helps establish precise methodologies, ensuring a smooth path to commercialization & covers the current FDA expectations to avoid any unexpected deficiencies to avoid any major rework and avoid delayed in approval.

API facility template + IIG + size & shape templates and many more

Industry best practices, such as API Facility tools, help identify hidden or non-DMF-listed facilities. The IIG Checklist ensures FDA compliance across 12+ dosage forms, reducing RTR risks. Standardized evaluations enhance submission quality, while Size/Shape Templates minimize CR letters, streamlining approvals and facilitating smooth regulatory inspections.