Kolter AI offers an autonomous planning engine that leverages codified regulatory intelligence to manage complex site transfers and CDMO switches for life‑science products across multiple markets. The platform generates detailed computing requirements, timelines, and risk assessments for jurisdictions such as the USA, EU, Japan, Brazil, China, and India, allowing teams to maintain control while the system runs the planning workflow automatically.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical companies must coordinate complex lifecycle changes—such as site transfers, supplier switches, formulation updates, labeling revisions, and post‑merger integrations—across dozens of markets. Each change triggers multiple regulatory submissions, timing constraints, and cross‑functional dependencies that are currently tracked on outdated spreadsheets, leading to missed deadlines, increased risk, and lost market access.
Solution
Kolter AI offers an autonomous planning engine that codifies regulatory intelligence for more than 80 countries and embeds 17 years of change‑management expertise. Users input a change request, and the platform automatically computes market‑specific regulatory requirements, submission pathways, timelines, critical‑path dependencies, and risk assessments across functions such as CMC, supply chain, labeling, and quality. The system integrates data from RIM, ERP/SAP, QMS, and PLM sources, then delivers a consolidated execution plan, cost and effort estimates, and scenario‑planning capabilities, while keeping the user in control of final decisions.
Target Audience
Primary users are CMC/operations managers, regulatory affairs teams, labeling specialists, quality leaders, supply‑chain planners, and integration project leads within pharmaceutical companies that manage multi‑market product changes.
Features
- Codified regulatory intelligence covering 50+ market requirements, grace periods, and bundling rules, linked to source regulations
- Autonomous planning engine with 50+ computation modules that generate country‑by‑country submission timelines, critical paths, and cost models
- Cross‑functional execution plan that sequences CMC, supply, labeling, and quality activities with dependency tracking
- Instant scenario planning to re‑evaluate “what‑if” changes across markets in minutes
- Early risk identification with severity scoring, cascade detection, and mitigation recommendations
- Automatic cost and effort estimates for regulatory fees, FTE effort, and revenue at risk
- Integration with existing enterprise systems (RIM, ERP/SAP, QMS, PLM) to pull product, inventory, and change‑control data