Introducing Kolter AI

The autonomous planning engine, powered by encoded regulatory intelligence.

Built to run on its own. · Designed to keep you in command.
Kolter AI: your strategist and execution partner, turning your change program into a market-level plan where the dates align, scenarios run in minutes, and risks come with mitigations.
Kolter AIComputing
MS
Site transfer to a new CDMO. 6 markets, marketed product. Plan it.
K
On it. Planning your site transfer across 6 markets:
USAEUJapanBrazilChinaIndia
Computing requirements, timelines and risk
MarketPathwayGrace periodTrigger
USAPAS (prior approval)Mfg stops at approvalApproval
EUType II (major)Mfg: 180 daysQP release
JapanPCA (partial change)Mfg stops at approvalApproval
BrazilPrior approval (5f/5g)Mfg stops at approvalApproval
ChinaSupplementary applicationMfg stops at approvalApproval
IndiaLevel I (prior approval)Not applicableApproval
Submission timeline · critical path
USA
EU
Japan
Brazil
China
India
Change intake
Site transfersCDMO switchesMAH transfersSupplier changesFormulation changesLabeling updatesPost-merger integrationDivestitures
Kolter AI isn't a thesis. It's 17 years of running the hardest changes in global life sciences, encoded into a system your team can run.
$100B+
In deal value navigated
80+
Countries' rules worked across
125+
Programs run across the lifecycle
The problem we solve

Does this sound like your week?

If you lead CMC / Operations

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set off a cascade of submissions, and now you are tracking them across forty markets on a spreadsheet that is already out of date.

If you lead Regulatory

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.

If you lead Labeling

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.

If you lead Quality

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.

These are not four problems. They are one problem, lifecycle change, seen from four seats.
And it has never had a system built for it. Until now.
Why now

This used to be manageable. It isn't anymore.

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. Every delay now costs market access and revenue.

Where everyone else stops

The industry spent millions on the wrong problem.

Where the tools stop

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.

Kolter AI
They search.
We compute.
Give Kolter AI a change. It returns the requirements, the timing, the cross-functional constraints, and what is at risk if you miss, before a single affiliate is contacted.
How it works

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.

01

Encoded regulatory intelligence

What is required in every market, traced to the source regulation. The data no one else has.

02

Autonomous planning

50+ computation engines, encoded from decades of planning complex programs. The methodology, not generic AI.

03

Human command

Kolter AI drives the plan to completion. You stay in control at the decisions that carry consequence.

What it does

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.

Where Kolter AI fits

Pulls from your systems. Replaces the manual layer. Delivers the plan.

Pulls from your systems
RIM
Registration history, submissions, status
ERP / SAP
Product master, site data, inventory
QMS
Change control, deviation history
PLM / Labeling
Pack components, artwork versions
Kolter AI
Combines your product data with encoded regulatory intelligence, then computes the plan.
Kora DB · 50+ markets of requirements, grace periods, bundling
Planning engine · timelines, cost, critical path
Risk analysis · severity scoring, cascade detection
Execution tracking · actuals vs. plan, replanning
Delivers the plan
Cross-functional plan
Reg, CMC, supply, labeling — sequenced
Submission timeline
Country-by-country, with critical path
Cost model
Fees, FTE effort, revenue at risk
Risk register & scenarios
Scored risks, side-by-side what-ifs
EliminatedThe unstructured middle no system owns today
×
Affiliate surveys50+ markets surveyed manually, every time, from scratch
×
Spreadsheet planningExcel and email chains across 6+ functions
×
$500K–1.5M consultingOutside planning help, per change event
×
Tribal knowledgeIn people's heads, not in a system

Give us your change. We'll give you the global plan.

Every market, every submission, every grace period, every risk, in minutes. Computed from the same regulations your team would otherwise spend months reading.

Every marketCountry levelSKU levelRegistration levelGrace periodsRisk & mitigationInstant scenariosBundling
Built to be trusted

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.

Traced to source
Every requirement maps to the primary regulation, not a model's best guess.
Human in command
You approve every consequential step before the plan moves on it.
Validated, not improvised
Tested against a validated regulatory corpus before it ever runs on your change.
Why Kolter AI

Built from the playbook, not from a whiteboard.

Megha Sinha, Founder and CEO

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, encoded. The judgment that used to live in a handful of heads, now in a system your whole team can run.

Megha Sinha · Founder and CEO, Kamet Consulting Group
Return on investment

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.

Open the ROI calculator →
Get started

Bring us your change.

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.

We'll get back to you personally. No spam, ever.