Wasted on non-value-added compliance work as part of commercialization.
(errors, rework, audit prep, submission prep, tedious tasks, etc.)
Affected on average by compliance work.
($21M for a complex medical device prior to commercialization)
In compliance budgets year-over-year.
(5000+ pages of fragmented regulations and increasing, reduced reliance on cross-country approvals, 100+ new standards per year, etc.)
Work with an AI agent to develop a go-to-market (regulatory, quality, clinical) strategy based on product complexity, current landscape, and estimated time/cost.
Automatically generate compliant, audit- and submission-ready documentation - what you need, when you need it, without wasting effort on throwaway work.
Analyze the market and other similar products, map your growth trajectory - all while maintaining compliance for your current products.
From the quality, regulatory, and clinical trenches.
From the AI-enabled medical development trenches.
Reduce risk, eliminate bottlenecks, and fast-track approvals - all in one platform.
AI-powered insights help pinpoint the fastest regulatory pathway.
Spend less time messing with templates and instantly generate submission-ready documents.
Catch compliance gaps early to avoid costly delays and more work.
Create the required set of documents, and understand why.
Handle submissions and complex products with ease, so that you can focus on growing your business.
Free up time to focus on high‑impact, strategic advisory instead of repetitive tasks
Expand into a wider range of product categories with AI‑assisted regulatory and quality support
Scale your consulting capacity and win more projects without dependence on extra staffing
Deliver faster, more consistent client outcomes using AI agents
Maximize efficiency, reduce idle time, and fast-track tedious reporting.
Audit faster with instant access to organized, AI-extracted evidence and documentation
Eliminate tedious prep— go into audits with automated traceability and risk summaries
Spot gaps and nonconformities with AI trained on real regulatory enforcement trends
Standardize findings and streamline reporting with intelligent audit templates
