Our Services

At CMC-AI, we recognize the complexities and challenges of bringing new drugs to market. Our CMC AI services provide Pharma and Biotech companies with intelligent solutions that seamlessly integrate into a spectrum of CMC processes, driving efficiency across the board.

Use Cases

Understanding CMC Landscape

Designed to focus on searching through publicly available Prescribing Information of commercially approved products for CMC specific information. It provides an efficient tool to CMC scientists in understanding the formulation landscape.

Reg CMC Document Preparation

Designed to focus on searching through client companies’ development reports using AI tools to extract relevant information for insertions into INDs, NDAs or other regulatory templates. After reviewing these populated templates, the finalized CMC sections can be part of the entire regulatory submissions.

Retest/Expiry Management

Designed to provide Expiry Dating Management using an internally developed platform which tracks and update the dating based on stability results. The platform consists of algorithms which incorporate a stability protocol framework and regression analysis to predict/manage the retest/expiry dating.

Forecasting DS & DP Requirements

Designed to provide Forecasting Drug Substance & Drug Product Requirements using a computational modeling program that analyzes the study-specific requirements. The platform consists of exclusive algorithms (for different dosage forms) which incorporate a variety of different assumptions to forecast requirements for nonclinical and clinical studies.

Quality by Design

Designed to provide Quality by Design (QbD) analytics tools that guide a CMC scientist in experimental design, collection and analysis of data. The tools subsequently identify design spaces & outliers to empower CMC scientists in adopting risk-based approaches recommended by the US regulatory agency.

AI Consulting

We specialize in custom CMC AI development to precisely meet and exceed the unique needs of your organization and enable you to move drug development with speed and efficiency.

Why Choose Us?

Choose CMC-AI because it's developed by CMC Scientists for CMC Scientists, where innovation meets efficiency to redefine your scientific experience.

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Cutting-Edge Technology

Stay ahead of the curve with our commitment to staying at the forefront of AI technology.

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Data Security and Privacy

We prioritize robust security measures to safeguard your sensitive information, ensuring compliance.

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Dedicated Support

Our dedicated support team ensures that you receive prompt assistance.

Industries We Serve

We empower small and large Pharma and Biotech companies with AI solutions that seamlessly integrate into a spectrum of CMC processes, driving efficiency across the board.

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Eager to Serve

Small Pharma and Biotech Companies Need A Comprehensive Platform

CMC-AI is uniquely positioned to support emerging companies with an innovative, efficient, cost effective and comprehensive platform to manage various CMC processes.

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Willing to Serve

Large Pharma and Biotech Companies Need An Optimized Platform

CMC-AI is proud to highlight its collaborative culture to optimize solutions to achieve efficiency with innovative AI tools to move development with speed and efficiency for large companies.

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Easing Burden on CMC Scientists

Harnessing AI for CMC Development

CMC scientists are constantly juggling their time between science and operation. An AI based platform developed by CMC-AI ties multi-faceted CMC processes efficiently together that significantly ease burden on CMC scientists.