Chemistry, Manufacturing & Controls
Accelerate the path from drug development to delivery through chemistry, manufacturing and controls (CMC) digital transformation. Use AI and CMC analytics solutions to optimize process development, digitize knowledge transfer and strengthen regulatory compliance. Make treatments available to patients faster.
WHAT WE DO
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 leveraging process 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 leveraging 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.
HOW WE DO IT
ZS’s approach
With deep CMC domain expertise, digital transformation strategies and in silico modeling, we help reduce timelines from drug development to delivery through integrated design, data management, AI and analytics solutions.
Strategy design
We use our domain and industry expertise to help design your CMC digitization roadmaps, accelerated tech transfer plans and labs-of-the-future design.
CMC accelerators for faster turnaround
We leverage accelerators to build solutions for our CMC clients, including in the tech transfer, computational modeling and regulatory affairs space.
Cross-functional expertise
We integrate diverse skill sets to provide comprehensive solutions across various CMC engagements—domain, data and tech, AI and strategy.
Digitization-first approach
We identify opportunities to digitize and automize, ranging from experiment designs to lab of the future and tech transfer.
Related solutions
Manufacturing Decision Studio
Manufacturing, Engineering & Quality
Supply Chain Design & Planning
Our Team
Steve Yu
Principal
Supply Chain & Manufacturing
Suraj Pai
Principal
Supply Chain & Manufacturing
Prasanth Pogalore Jayaraman
Associate Principal
Supply Chain & Manufacturing
Nupur Sharma
Associate Principal
Supply Chain & Manufacturing
Prashant Kumar
Associate Principal
Supply Chain & Manufacturing