Mesa Science Associates has the expertise to evaluate the active pharmaceutical ingredient (API), characterize the API, and design a formulation that meets the medical need and is manufacturable and tested appropriately on development through commercial scales. In addition to the dosage form design and manufacturing, we have experience with developing tests and recommending specifications that meet the expectations of the reviewing Health Authority for each stage of development. Mesa Science will guide our client to ensure the CMC section is populated with appropriate data to get regulatory approval for the drug investigation or drug approval. Some of the CMC supporting documents are listed below
- 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.