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.