i-GENTIC expands GENIE to cover FDA compliance lifecycle
Fri, 8th May 2026
i-GENTIC AI has expanded its GENIE platform to cover the full FDA compliance lifecycle for life sciences companies. The system is designed to check consistency across regulatory submissions in real time.
The update addresses a common problem in drug and device approval filings: delays often stem not from missing data, but from conflicting information across large submission packages. GENIE applies contextual reasoning across regulatory documents, including PDFs, Common Technical Document modules, datasets, standard operating procedures and FDA frameworks.
At the core of the product is a system that converts regulatory requirements into machine-readable rules, then compares statements, terms and numbers at both sentence and data level. This allows the software to identify inconsistencies across different parts of a filing and explain why they matter in regulatory terms.
"Cross-document consistency is one of the major roadblocks when submitting a drug or device for approval, so GENIE continuously validates that every claim, every number, and every statement aligns across the full submission package," said Zahra Timsah, Founder and Chief Executive Officer of i-GENTIC AI.
Timsah gave the example of clinical efficacy data appearing as 68 per cent in one section, 72 per cent in product labelling, and with a differently defined cohort in a statistical appendix. In that case, she said, the system would treat the issue as a conflict and produce a suggested correction linked to the original source material.
"If clinical efficacy data says 68 percent, labeling says 72 percent, and the statistical appendix defines the cohort differently, the system understands that these are conflicts, and suggests corrections. GENIE traces every suggestion back to the original source," said Timsah.
The company is targeting biopharma, medtech and biotech organisations that face long regulatory processes and repeated review cycles. Alongside checks within a single submission, GENIE is designed to track changes across filings made months apart, such as between an Investigational New Drug application and a Biologics Licence Application.
Tracking changes
That matters because definitions approved in an earlier filing may drift by the time a later application is prepared. The software can monitor those version changes and flag deviations that may require explanation or supporting evidence.
"In this case, GENIE monitors IND to BLA version changes and nuanced deviations," said Timsah.
"GENIE determines the PFS correction requires proof and generates the traceability report automatically, so regulatory teams can demonstrate that what was submitted is consistent with what was studied and approved," said Timsah.
The platform also aims to move compliance checks earlier in the document creation process. Rather than reviewing drafts only after they are written, GENIE can connect to document management systems, quality management systems and electronic trial master file systems to test content against regulatory rules as it is being drafted.
That could be used for documents such as 510(k) submissions, BLAs and INDs, where wording in an intended use statement or a clinical claim can affect how regulators assess the filing. The software is presented as a way to reduce late-stage revisions and requests for clarification.
"When someone writes a 510(k) intended use statement, GENIE validates it against FDA rules and can determine if the statement is too broad," said Timsah.
"The system makes a suggestion as the author is creating or editing a document, eliminating after-the-fact compliance checks that slow down the submission process," said Timsah.
External views
The company also included comments from executives and advisers in healthcare, risk and pharmaceuticals. Their remarks focused on the need for tighter oversight of artificial intelligence in regulated sectors and the value of embedding compliance controls directly into day-to-day workflows.
"i-GENTIC enables innovation without compromising oversight, which is exactly what healthcare needs right now," said Dr. Jean-Pierre Issa, President and Chief Executive Officer of the Coriell Institute for Medical Research. "The platform bridges the gap between advanced AI capabilities and the governance required to use them responsibly."
"i-GENTIC is positioning governance as a foundational layer of modern healthcare infrastructure. This is a shift from managing risk after-the-fact to preventing it in real time."
Richard D. Daniels, former Chief Information Officer at Kaiser Permanente, also commented on the use of AI in healthcare settings.
"i-GENTIC introduces a level of trust and control that is critical for deploying AI safely in healthcare. With i-GENTIC, compliance is no longer reactive, it becomes part of the execution layer," said Daniels.
Prince Nasr Harfouche, Partner, Risk Services at KPMG, pointed to wider changes in how organisations manage controls.
"The shift from static compliance to real-time governance is inevitable," said Harfouche.
"Enterprises need solutions that move beyond monitoring and reporting, toward continuous enforcement of policies, regulations, and internal controls."
Scott Howell, former Chief Marketing Officer at Novartis, said the approach could change how compliance is handled in operational settings.
"i-GENTIC transforms compliance from a bottleneck into a streamlined, continuous process. By embedding governance directly into workflows, i-GENTIC reduces risk while improving operational efficiency," said Howell.
GENIE is model-agnostic, allowing life sciences companies to run it alongside existing artificial intelligence systems. The platform can also be extended to areas such as contract review, and i-GENTIC said it is working with organisations across medtech, pharma and biotech to make GENIE the central layer for regulatory governance.
"Life sciences companies that had to figure out what went wrong with a submission, now have a system that can course-correct any errors before hitting 'submit'," said Timsah.