Regulatory Labs AI Platform is redefining regulatory compliance in Pharma and Cosmetics with AI

Regulatory Labs AI Platform is redefining regulatory compliance in Pharma and Cosmetics with AI 

The Pharma and Cosmetics industries are facing increasing regulatory complexity, shorter innovation cycles and growing pressure to launch products faster without compromising compliance or safety. In this context, Xtremis has developed Regulatory Labs AI Platform, an AI-powered solution designed to transform the way laboratories, R&D teams and regulatory departments analyze and validate formulations. 

The platform allows users to upload a formulation - either manually or directly from a PDF document containing ingredients and concentration percentages - and automatically generates a complete regulatory analysis in just 3 to 7 minutes, a process that traditionally could take days or even weeks. 

Regulatory Labs AI Platform validates compliance across multiple jurisdictions including Europe, the United States and LATAM markets, detects restricted or prohibited substances, identifies critical interactions, calculates PAO (Period After Opening), proposes alternative reformulations and generates key regulatory documentation such as the PIF and marketing sheets. 

The platform is capable of operating in up to 148 languages, enabling laboratories and international teams to centralize regulatory analysis across global markets while dramatically simplifying collaboration between departments and regions. 

One of the platform's most innovative features is its conversational AI interface. Once the analysis has been completed, users can interact directly with the system through an intelligent chat to ask questions, request explanations, explore alternative ingredients or test formulation changes in real time. 

For example, a regulatory specialist can ask the platform to replace a component with another ingredient and instantly generate a new compliance report reflecting the updated formulation. The system also

incorporates version history and rollback capabilities, allowing teams to compare iterations and return to previous versions whenever needed. 

This transforms the traditional regulatory workflow into a dynamic and collaborative AI-assisted environment, where formulation, compliance and innovation can evolve simultaneously instead of operating as disconnected processes. 

By automating highly time-consuming regulatory tasks, Regulatory Labs AI Platform helps laboratories reduce validation times by more than 90%, minimize human error by up to 98% and significantly accelerate time-to-market while maintaining regulatory rigor and traceability.