Kamet Consulting Group Unveils Kolter™AI — an Autonomous Planning Engine Powered by Codified Regulatory Intelligence

Kamet Consulting Group today unveiled Kolter™AI, a new system for planning and managing product change across the life cycle in life sciences. Kolter AI computes how product changes play out across every market they touch — replacing manual planning with a single co-ordinated view.

Lifecycle change management, the process governing how pharmaceutical products evolve after regulatory approval, sits at the heart of every product. Yet despite its importance, it remains managed through spreadsheets, manual coordination and fragmented systems across regulatory, supply chain, quality and commercial teams.

This week, a global analyst firm highlighted a major unmet need in the market: the absence of any system that connects regulatory intelligence, planning and execution in a single, product-level view. This is the gap Kolter addresses.

Existing regulatory intelligence tools tell companies what the rules are; they don't codify the operational intelligence companies need to plan around them. So, every major change is rebuilt from scratch, and the result is predictable — delays, rising cost, supply disruption and no clear view of impact until it is too late.

"For nearly two decades I watched brilliant science stall after approval, changes taking months to plan and years to execute across markets, handled with spreadsheets and heroics. The industry accepted that as normal. Kolter doesn't. It computes the plan for a change across every market it touches, traced to the regulation it came from." — Megha Sinha, Founder and CEO of Kolter AI and Kamet Consulting Group

Kolter brings regulatory intelligence, planning and execution into a single environment. At its core is a proprietary regulatory intelligence layer built for planning, not reference: requirements are structured so Kolter can compute dates, dependencies and cross-functional sequence of a real program. On top of it, autonomous planning lets teams model, compare and execute change scenarios across markets, functions and timelines, before committing to any of them.

Crucially, Kolter is built for a regulated environment and shaped by deep, real-world experience of how lifecycle change actually works in pharma. It applies advanced AI to extract and maintain regulatory requirements at scale, then grounds every output in structured data, human validation and auditable logic, traced to the source regulation. The heavy, rule-bound work is computed; the consequential calls stay with a person. The result is intelligence that is both powerful and trusted.

"The regulators are converging on a clear standard for AI in this industry: risk-based, a human in command, and traceable to source. That's exactly how Kolter was built, powerful because it computes the hard work, trusted because every output traces back to the regulation it came from." — Mark Rutter, VP Regulatory Affairs, Formation Bio

That combination, the company argues, is a new layer of infrastructure, not another tool.

"Every life sciences company feels this problem, and until now no one has owned it. Kolter treats lifecycle change as computable infrastructure, not manual labor. That's a new category, not just a better tool." — Nancy Allen, former VP, Global Regulatory Affairs at Eli Lilly

Kolter arrives as life sciences organizations restructure around product-level ownership, pulling regulatory, supply, quality and commercial accountability under a single view of the product, a model that needs exactly this kind of system to be realized.

Kolter is now open to a small number of design partners. Companies can bring a real scenario, their product, markets and constraints, and see Kolter model, plan and execute it with full visibility before they commit. More at kolter.ai.

About Kamet Consulting Group

Kamet Consulting Group is a specialist life sciences consultancy focused on regulatory, quality and lifecycle transformation. It was founded by Megha Sinha, who led PwC's global life sciences regulatory practice and ran the regulatory and supply-continuity side of major M&A integrations and technology transfers across the industry. Kolter is the system she built from that experience.

The firm works with pharmaceutical, biotech and medical device companies on complex programs including M&A integration, regulatory strategy, AI-enabled transformation and global product lifecycle management. Kolter is Kamet's first technology platform.

PR Contact

Carina Birt, Sarum Life Sciences
carina@sarumlifesciences.com
+44 7970 006624