The Challenge
Preparing regulatory submissions—whether for drugs, biologics, or medical devices—is one of the most time-consuming tasks in the compliance lifecycle. Submissions must meet strict formatting rules (such as eCTD), maintain consistency across hundreds of documents, and comply with constantly evolving guidelines.
Errors in formatting, missing content, or inconsistencies can result in rejections or lengthy back-and-forth with regulators. For teams already stretched thin, submission preparation often becomes a bottleneck that slows time-to-market.
Our Solution
Lexim AI brings automation and intelligence to submission preparation. Our platform supports the end-to-end submission process, from assembling dossiers to validating content against regulatory requirements.
AI agents can format documents, compare versions, generate submission checklists, and flag gaps—dramatically reducing the manual workload. Whether it’s an FDA 510(k), an IND, or a global eCTD submission, Lexim AI helps ensure your dossiers are accurate, compliant, and submission-ready.
What Lexim AI Can Do For You
The Results
Companies using Lexim AI for submissions report cycle times reduced from months to weeks, fewer errors in their dossiers, and faster approvals. By automating the most repetitive aspects of submission preparation, teams can focus on strategy, quality, and communication with regulators.
Contact our team today to explore how Lexim AI can support your medical device compliance journey.