CMC in Pharma

What is CMC?

CMC (Chemistry, Manufacturing, and Controls) is one of the most important activities in drug product development. It occurs during all stages of the drug development cycle and ensures quality and consistency during the manufacturing of the pharmaceutical product. 

CMC is a critical component that cannot be overlooked. It ensures that the drug product has a consistent formula so that the drug used in clinical trials is the same as what is made commercially available. Because CMC applies to all stages of pharmaceutical development and focuses on creating consistency in drug product stability, release, and manufacturing, it must comply with FDA guidance. Without CMC, the product would be deemed unsafe and approval would be impossible.

Scientist in CMC Lab looking at data on monitors

Why Choose CMC Pharma for Chemistry, Manufacturing, and Controls?

There is a reason CMC is in our name: our main goal is to help develop new and better drug formulations, transforming innovative ideas into approved products. Our staff possesses decades of experience in formulation development and our bench scientists have extensive CMC experience in the development and manufacturing of traditional and complex dosage form drug products. We have prepared CMC sections for dozens of IND applications and are skilled in authoring and reviewing regulatory sections required to initiate human clinical trials.

While we don’t offer commercial-scale manufacturing capabilities, we provide all of the development services to ensure your drug product meets all requirements for FDA approval. Our services include pre-formulation and formulation studies, development of analytical methods, ICH stability and compatibility studies at a wide range of conditions, and dosage form design. In addition, our pilot plant allows us to create prototypes of solid and liquid dosage forms, allowing the new formulations to be produced at a small scale to support clinical trials.

We Help Timelines

Many vertically integrated companies offer a full range of development and manufacturing capabilities but these large CDMOs will not put their total focus on your project. Instead, CMC Pharma focuses strictly on the formulation aspect of drug product development and helps keep your drug development program on track. We stay up to date on current FDA guidelines and regulatory requirements and are committed to supporting successful filings. Although we don’t manufacture commercial-scale drug products, we assist with tech transfer and are connected with manufacturing organizations around the world.

We thoroughly understand the complexities of regulatory filing for NDAs. Our extensive experience allows us to get your new drug approved as expeditiously as possible. When it comes to development in pharma, CMC and timelines are two of the most important things.

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    What CMC Services Do You Require & How Can We Help?

    Contact Us Today to advance your drug development program.

    The scientists at CMC are experts in Chemistry, Manufacturing, and Controls for all stages of the drug development cycle. Whether you need to reformulate an existing product or need help filing an NDA, we can help.

    Send us a message or give us a call at 440-485-1734