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AI Engineering for Regulatory Affairs

We automate CTD submission assembly, variation tracking across 40+ markets, and dossier formatting — built and operated for you.

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What We Automate

We don't know every problem in your operation. You do. These are the types of work we engineer AI for. You tell us where it hurts most.

Data Entry Automation

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Your team re-types data from one system to another. We eliminate that.

CTD module data submission forms regulatory databases

Report & Document Drafting

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Dossiers and submission packages assembled from templates and source data automatically.

eCTD assembly variation applications briefing documents

Compliance & Audit Readiness

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Every inspection is a fire drill. We keep you ready all the time.

FDA inspections EMA audits GxP compliance

Regulatory Monitoring

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Rules change constantly across markets. We track them so your team doesn't miss a deadline.

FDA guidance EMA guidelines market-specific requirements

Incoming Request Processing

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Health authority queries come in from multiple markets. We classify, route, and track responses.

deficiency letters information requests commitment tracking

Report & Dashboard Consolidation

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Submission status across dozens of markets assembled into one view automatically.

submission trackers approval timelines market launch readiness
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Common Questions About AI for Pharma Regulatory Affairs

How do we start?
We start with a 2-week AI Roadmap. Our engineers spend time inside your regulatory affairs operation — watching your team assemble submissions, mapping your CTD workflows, measuring your volumes. 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 in parallel while your team works normally. Once accuracy is validated (typically 2-3 weeks), we switch over. Your team starts reviewing AI-assembled dossiers instead of building them from scratch. The transition is gradual, not a big bang.
How does this work with our regulatory systems?
We build on top of your existing systems. We integrate with Veeva Vault, IQVIA RIM, and every major regulatory information management platform. The AI layer connects systems that don't talk to each other today. Your IT team keeps managing infrastructure. We build the automation that sits between your systems.
What about FDA and EMA submission requirements?
Every workflow we build respects regulatory requirements. For eCTD submissions, the AI assembles documents and validates formatting — your regulatory team reviews and approves. We maintain audit trails for every automated step. The AI doesn't make regulatory decisions; it eliminates the manual assembly work around submissions.
How do we measure success?
We define success metrics with you before building anything. Typical metrics: submission assembly time, variation tracking accuracy, dossier formatting cycle time, and regulatory query response speed. 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 variation 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.

Your submissions are too complex for manual assembly.

Book a free 30-minute AI Assessment. We'll map your highest-volume regulatory workflows and show you the 3 processes with the highest ROI.

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