We have the expertise to evaluate your active pharmaceutical ingredient (API), characterize it, and design a formulation that meets its associated medical needs. Every formulation is developed and tested appropriately through commercial scales.
In addition to the dosage form design and manufacturing, we have experience with developing tests and test methods. We will recommend specifications that meet the expectations of the reviewing Health Authority for each stage of development. We will provide guidance for every client to ensure the CMC section is populated with appropriate data—a vital step in gaining regulatory approval for the drug investigation or drug approval. Some of the development steps we assist with in the CMC drug development process are listed below.
CMC Drug Development Documents
- API and API salt/crystal form selection.
- Process optimization and ruggedness evaluations of the API synthesis route.
- API process impurity and degradation product characterizations.
- API packaging, stability protocols, and stability reports.
- API and Product Test Method Development and Validation and specification limits for test results.
- Product dosage form selection; tablet, oral liquid/suspension, topical, inhalation or parenteral.
- Product formulation studies including solubility, excipient compatibility and stability to stress conditions.
- Product manufacturing process development and scale-up studies along with the required ruggedness and validation requirements.
- Product stability protocols and reports.
For further questions regarding our CMC drug development services, please get in touch with us. We’ll be happy to take you through our process and provide the information and guidance that will lead you to success!
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