CMC provides a multitude of high quality lab services made possible by our broad history in the pharmaceutical industry and highlighted with our ability to customize services to your specific needs.
We have evaluated the solubility of active pharmaceutical ingredients in a number of pharmaceutically relevant solvents.
Our liquid chromatography instrumentation provides capabilities to precisely test a large range of substances to determine potency, purity, degradation, composition, etc.
Our LC mass spectrometry detector provides a valuable tool for method development, impurity & degradant identification, and a variety of trouble shooting applications.
Our USP dissolution apparatus provides capabilities to execute the dissolution of a wide variety of dosage forms by the USP and other compendial requirements.
Our temperature and humidity controlled stability chambers are used in a variety of long-term, accelerated stability, and forced degradation studies.
CMC provides Formulation and Drug Product Development Laboratory Services to our clients. Our decades of experience in pharmaceutical development and our modern R&D laboratory are ideally suited to meet all of your drug product development needs.
Authoring & review of CMC regulatory filings is one of our core competencies. We have extensive experience in preparing drug product documents for INDs, NDAs, FDA queries, supplements and amendments, annual reports, site inspection observations, 483's and warning letters.
CMC has provided clients with technical support during due diligence for product out- and in-licensing as well as technical support for M&A activities. We have also provided business development support for technologies that require extensive technical interactions.
The successful development of a pharmaceutical product requires a well functioning project team. CMC has provided significant expertise and contributed to virtual product development and manufacturing teams. Providing decades of experience in a cost effective manner for a project can significantly reduce overall costs while expediting development.
Dosage preparation instructions are required for INDs, NDAs, non-clinical and clinical protocols, and investigator's brochures. We have extensive experience in reviewing and preparing these documents.
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.
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.
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.
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.
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.