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.
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.
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.
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.