Chemistry, Manufacturing & Controls
Challenges we solve
Optimize process development
Digitize CMC workflows, embed AI in experiment design and integrate CMC data management and analytics solutions. Use gen AI to streamline document authoring and enhance decision-making across process development.
Accelerate digital tech transfer
Implement the roadmap for streamlined information sharing between labs and sites by using digital twins, intelligent recipe management and AI-driven insights. Accelerate deviation assessments and shorten the time to process validation.
Data management and CMC ontologies
Standardize information collection through comprehensive ontologies across all modalities—process and analytical. Build the foundation for information retrieval by using knowledge graphs and large language models.
Regulatory strategy
Align your regulatory strategy with FDA and ICH guidelines. Accelerate dossier authoring using gen AI and FHIR standards.
Our approach
Explore our products and capabilities