RA-AI Tools

iTechnicalTools

Innovative AI (artificial intelligence) Technical tools to file quality applications which minimize the deficiencies and “483 database” to minimize the observations & other RA tools.

Regulatory approval procedures are becoming increasingly stringent and time-consuming. Not having the right regulatory strategy and Technical tools in place will cost time and money and may result in the failure or delay of your application, and acceptance and lead to Major CRs.

These tools help organization to get straight ANDA acceptance, No repeated deficiencies & minimize MAJOR CRs & enhances compliance tracking with real-time insights for improvement.

Increase your program’s chance of expedited success, iCretegy team provides robust regulatory strategy, consulting, and regulatory submissions support for your application with customized iTechnicalTools from filing, amendment, approval to life cycle management.

Artifical Intelligence (AI) LLM based Database

483 Observations Database

This Ai based database organizes and structures 9,000+ Form 483 observations. It includes observations from all 6 systems: Quality, Production, Facilities & Equipment, Laboratory Controls, Materials, and Packaging & Labelling, which proactively minimizes observations and ensures maximum compliance. Users can search observations by Company name, Investigator name, System type, and Year of inspection, Keyword etc. for targeted analysis along with warning letter. Specific observations can be printed as PDFs as needed.

FDA Deficiency Database

The FDA Deficiency Database stores 5,000+ FDA deficiencies, covering 8+ dosage forms to offer in-depth regulatory insights & meets current expectations of Agency. It includes 20+ deficiency types and features eCTD & CMC Acceptance Deficiencies, streamlining the approval process. By proactively identifying and addressing potential deficiencies, it helps minimize regulatory hurdles, reduce review cycles, risk of RTR and accelerate product approvals for timely market launches which benefits to the organization.

Complete Response Database

The Complete Response database stores 900+ potential FDA’s major deficiencies, covering 8+ dosage forms to offer in-depth regulatory insights. It features 15+ deficiency type options, enabling early gap identification through semi AI-driven analytics to address issues before submission. By minimizing major rework, it streamlines the review cycle, facilitates first-cycle approvals, and ensures a timely product launch. It also helps in reducing the organizational cost.

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.