How do we start?
We start with a 2-week AI Roadmap. Our engineers spend time inside your regulatory operation — watching your team assemble submission packages, mapping your health authority correspondence tracking, measuring your CMC variation management cycle. The output is a ranked list of workflows by ROI, with implementation timelines and expected savings. No commitment to build beyond the roadmap.
What does my team do differently on day 1?
Almost nothing. The first workflow runs alongside your existing process — AI assembles submission components or tracks correspondence in parallel while your team works normally. Once accuracy is validated (typically 2-3 weeks), we switch over. Your regulatory team starts managing strategy instead of document assembly. The transition is gradual, not a big bang.
How does this work with our regulatory information management system?
We build on top of your existing systems. We integrate with Veeva Vault RIM, LORENZ docuBridge, Ennov, and every major RIMS platform. The AI layer connects your RIMS, document management, and publishing tools. Your IT team keeps managing infrastructure. We build the automation that sits between your systems.
What about FDA and EMA submission format requirements?
Every workflow we build respects eCTD format requirements and regional submission standards. The AI validates document structure, cross-references, and granularity against ICH guidelines. We maintain audit trails for every automated step. The AI doesn't make regulatory strategy decisions; it eliminates the manual work around submission preparation.
How do we measure success?
We define success metrics with you before building anything. Typical metrics: submission assembly time, correspondence response turnaround, CMC variation preparation speed, and deficiency letter response time. We set up dashboards that show before/after in real-time. If the numbers don't improve within 90 days, we fix it on our dime.
What's the total cost for year 1?
Two options. Per Workflow: $25K-$75K per workflow, best for starting with one high-impact process like submission assembly or correspondence tracking. Dedicated Team: ~$22K/month for 2+ AI engineers embedded in your operation, building multiple workflows continuously. Most regulatory teams start with one workflow, prove the ROI, then move to a dedicated team.