CMC provides technical consulting expertise to the pharmaceutical and biotech industry, and our extensive and collective experiences provide us the ability to provide valuable input on a broad range of topics.
Preformulation Characterization
These studies can be customized to include excipient compatibility, solid form evaluation, solubility measurements in pharmaceutically acceptable solvents, pKa determination, forced degradation studies, pH degradation rate profile, evaluation of adverse conditions (water/humidity, temperature excursions, oxygen, light, freeze/thaw, etc.) and other studies as needed to evaluate and active pharmaceutical ingredient (API) for pre-clinical or clinical studies.
Formulation Development
CMC can execute studies and evaluate the physicochemical properties of an API and recommend an appropriate dosage form for preclinical and clinical studies. Prototype formulations are prepared and evaluated under stressed, ICH, and custom conditions. We have extensive expertise in evaluating the stability and compatibility of drug products at various storage and in-use conditions to support stability during clinical trials and commercialization and in support of IND and NDA filings.
Small Molecule Analytical Characterization
CMC’s is well equipped to analyze drug products by a number of advanced techniques that include HPLC, UPLC, UV/V is spectrophotometer, visual analysis, and other analytical techniques. Our Cleveland Health-Tech Corridor location provides financial incentives to purchase equipment and access to a wealth of advanced lab services at the area’s universities and hospitals.
Formulation Preparation: Solid Oral and Sterile/Nonsterile Liquids
CMC can prepare a number of traditional and complex dosage forms for in vitro and in vivo exploratory, proof-of-concept, and toxicology studies. We can provide the appropriate analysis and documentation to support each stage of development.
