iPharma AI helps pharmaceutical teams simplify regulatory operations, strengthen inspection readiness, accelerate ANDA workflows, and proactively manage compliance risk using AI-driven inspection intelligence and audit analytics.
Every pharma organization faces growing pressure across inspections, Regulatory submissions and operations. Without compliance intelligence, structured CTD templates, and smart regulatory workflows, teams risk delays, recurring observations, warning letters, and lost market trust.
Without visibility into investigator strictness history, recurring inspection patterns, and site-specific risk trends, facilities walk into inspections unprepared - increasing the likelihood of critical observations and import alerts.
Using outdated templates and fragmented documentation workflows increases FDA deficiency letters, response cycles, and submission review delays.
Managing evolving regulations, submission timelines, and compliance activities across disconnected systems creates operational bottlenecks and limits regulatory efficiency.
iPharmaAI brings together expert-built regulatory tools, inspection intelligence, and smart CTD drafting support to help pharma teams work faster, review better, and reduce avoidable compliance and submission risks.
A global inspection intelligence platform covering USFDA 483 observations, EU EudraGMDP records and UK MHRA GMDP certificates - with 8 purpose-built modules for pre-audit readiness, investigator intelligence, cGMP checklists, recurring violation analysis, company benchmarking and warning letter tracking.
A smart ANDA documentation support solution that helps teams draft and review CTD sections using structured templates, checklist logic, guidance expectations, and deficiency intelligence.
A structured hub for regulatory checklists, templates, review tools, controlled correspondence support, DMF review, validation checks, and strategic regulatory execution.
Audit IQ
Audit IQ converts global inspection data from FDA, EU EudraGMDP and UK MHRA into searchable, filterable, decision-ready intelligence - covering USFDA 483 observations, warning letters, investigator profiles, cGMP pre-audit checklists, recurring violation patterns and company benchmarking for proactive inspection readiness and compliance visibility.
RegX helps regulatory teams move from scattered files and manual review practices to a structured, standardized, and expert-driven regulatory tools ecosystem. A comprehensive suite of 10+ regulatory intelligence tools covering ANDA checklists, DMF, validation, IIG clearance and facility templates for API & FDF.
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.
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. By addressing key requirements early, it minimizes rework and deficiencies, increasing the chances of 1st cycle approval.
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 to save time and increase chances of straight FDA acceptance.
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. Usable for own DMF as well as other Vendor's DMF for Open part review.
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 covers the current FDA expectations to avoid unexpected deficiencies and major rework delaying approval.
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.
"With iPharmaAI, we can leave the noise behind. It gives us focused FDA 483 and Warning Letter intelligence in one place. The insights help us understand trends, prioritize risks, and strengthen inspection readiness with confidence."
US Chief Quality Officer - Amneal Pharmaceuticals, USA
Transform how your teams prepare submissions, analyze FDA trends, manage inspections, and stay continuously audit ready with iPharma AI.
Schedule Consultation