The autonomous planning engine, powered by codified regulatory intelligence.
Does this sound like your week?
One site transfer or supplier change just set off a cascade of submissions, and now you are tracking them across forty markets on a spreadsheet that is already out of date.
You are staring at a stack of changes, working out which can bundle into a single submission and which have to stand alone, market by market, with the clock running on every one.
You are pushing one safety update through every country before each local deadline lapses, with no clear view of which markets are about to slip.
You own the change on paper, but the work lives in four other functions, and you are the one who finds out last when something is late.
You just closed the deal, and now you have to rebrand and re-file a portfolio across a hundred markets, with the integration clock already running.
A site or supplier change means timing inventory build, old-stock sell-through, and cutover across every market, so nothing goes out of stock or out of compliance.
Everyone built tools to track. No one built one to compute.
A handful of changes a year is now dozens, driven by M&A, supply-chain restructuring, and patent cliffs, and handled by smaller teams. The spreadsheets and affiliate surveys that used to absorb it are breaking, and every delay costs market access and revenue.
Project management tools track the work. They do not tell you what work needs to happen.
Regulatory intelligence gives you high-level change categories. It does not give you the operational intelligence to execute a program: the dates, the dependencies, the cross-functional sequence.
We compute.
Three layers no one else connects into a single system.
The heavy, rule-bound work, every market's requirements, the dates, the dependencies, Kolter AI computes. The calls that need a human, what risk to accept and what to prioritize, stay yours.
Codified regulatory intelligence
What is required in every market, traced to the source regulation. The data no one else has.
Autonomous planning
50+ computation engines, codified from decades of planning complex programs. The methodology, not generic AI.
Human command
Kolter AI drives the plan to completion. You stay in control at the decisions that carry consequence.
If a change touches it, Kolter AI computes it.
Not a dashboard of alerts. The full operational answer, every dimension of the change, in one place.
Regulatory requirements, market by market
What's required in each country, traced to the source regulation.
Cross-functional execution plan
Timelines, dependencies, and critical path across every function.
Grace-period analysis
What happens to old product after approval, and exactly when it must stop.
Risk identification & mitigation
Every risk surfaced early, with the mitigation, before it hits.
Instant scenario planning
Re-plan any what-if across markets and functions in minutes, not weeks.
Bundling & worksharing
Which changes combine into one submission, and which must stand alone.
Cost & effort estimates
Regulatory fees, cross-functional effort, and revenue at risk.
Program tracking to completion
Driven forward across functions, with alerts when something slips.
Pulls from your systems. Replaces the manual layer. Delivers the plan.
Registration history, submissions, status
Product master, site data, inventory
Change control, deviation history
Pack components, artwork versions
Reg, CMC, supply, labeling — sequenced
Country-by-country, with critical path
Fees, FTE effort, revenue at risk
Scored risks, side-by-side what-ifs
Autonomous where it's earned. Human-controlled where it matters.
Kolter AI's planning was not improvised by a model. It was tested and refined against a validated regulatory corpus, so the engine handles what it has proven it can handle, and a human stays in command everywhere else.
Built from the playbook, not from a whiteboard.
For seventeen years, getting the hardest product changes through global markets has run on the expertise of a few senior people and multi-million-dollar consulting programs. We have run that playbook on more than $100B in deal value.
Kolter AI is that playbook, codified. The judgment that used to live in a handful of heads, now in a system your whole team can run.
See how Kolter AI actually saves you money.
Put a number on what the manual way is costing your team, by function and by market, in about two minutes.
Bring us your hardest scenario.
We're inviting design partners to help shape Kolter AI. Share one real change from your world, your markets, your scenario, and we'll show you Kolter AI working on it.