Drug Development is Complex & Expensive

CMC is a critical component of the drug development process

Chemistry, Manufacturing and Controls (CMC) is a critical aspect of the new drug development and is an essential part of the regulatory approval process for eventual commercialization of new pharmaceuticals.

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The Staggering Cost of New Drug Development

Historically, the estimated cost of new drug development has spiraled. According to the Tufts Center for the Study of Drug Development (CSDD), the average cost of developing a new drug was approximately $231 million in 1990.

According to the Tufts CSDD most recent study published in 2020, the average cost of developing a new drug from discovery to approval has gone up to approximately $2.6 billion. In addition, it takes an average of 10.5 years to bring a new drug to the market.

The cost of CMC can vary depending on the complexity of the drug substance, drug product, manufacturing processes and the requirements of regulatory agencies. However, estimates suggest that CMC can account for up to 20-30 % of the total cost of drug development.

Our Services

Embark on a scientific journey of innovation with our integrated AI solutions, tailored to meet your CMC needs and drive unparalleled success.

Navigating 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 for CMC scientists to navigate the CMC landscape.

Reg CMC Document Preparation

Designed to focus on searching through internal development reports using a large language model and machine learning tools to extract relevant information for insertions into INDs and NDAs 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 a proprietary retest/expiry dating management algorithm which tracks and updates the dating based on stable results. The platform consists of algorithms that incorporate a stability protocol framework and regression analysis to predict/manage the retest/expiry dating.

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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.

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.

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.

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.

Frequently Asked questions

Explore the answers you seek in our “Frequently Asked Questions” section, your go-to resource for quick insight into the world of artificial intelligence related to new drug development.

From understanding CMC AI applications to learning about our services, we’ve condensed information you need to kick start your exploration of this transformation technology.

Getting started is easy. Simply contact our team through our website or reach out to our customer support. We'll discuss your specific needs and tailor a solution that aligns with your business goals.

Artificial Intelligence (AI) is a branch of computer science focused on creating systems capable of performing tasks that typically require human intelligence. These tasks include learning, reasoning, problem-solving, perception, and language understanding. Technology is rapidly evolving and has the potential to transform many aspects of our lives, from healthcare to entertainment.

Brief descriptions of five use cases are summarized under the “Our Services” Section. In addition, we provide custom CMC-AI development to precisely meet the unique needs of your organization.

Yes. In highly complex CMC functions, managers face myriad challenges from scientific research to balancing cost, time, quality and quantity for delivering the best possible outcome for the clinical trials and patients. CMC-AI can especially help small companies because of resource constraints (people and finance). CMC-AI can provide efficiency to the management of CMC processes.