CMC Pharmaceuticals, a leading provider of drug product development services, announces that it has updated its website to better describe its drug product development services. Since its founding in 2014, CMC Pharma has increased the depth and breadth of the chemistry services that it provides:
- FORMULATION DEVELOPMENT – CMC Pharma scientists are experts in the development of traditional oral, injectable and complex controlled release dosage forms. Scientists have contributed to developing drug products for a broad range of active pharmaceutical ingredients (API), including drug products that are challenging to stabilize, solubilize or need a sophisticated drug delivery system.
- DRUG DELIVERY SYSTEMS – CMC Pharma provides expertise in selecting and developing drug delivery systems. The company’s focus is not on its own proprietary drug delivery technology, but rather the selection of a drug delivery system that considers the target product profile and not one specific technology. CMC Pharma uses proven approaches to develop long acting drug product formulations and are specialists with extensive experience in formulation and analytical development of competing drug delivery technologies appropriate for active ingredients with varying characteristics.
- ANALYTICAL CHEMISTRY – CMC Pharma scientists have tested hundreds of pharmaceutical drug products, and our scientists are experts in method development, validation, and execution in techniques that include U/HPLC, LC- MS, Karl Fisher, osmolarity, dissolution, in vitro release testing and other analytical instrumentation. Our expertise includes development and validation of potency and related substances stability indicating methods. Testing experience includes evaluating APIs, drug products, excipients, and reference standards, including utilizing a vast majority of USP tests.
- STABILITY SERVICES – CMC Pharma executes a wide variety of standard ICH and custom designed stability studies to support the development and approval of drug products and APIs. Studies can be performed following cGMPs, when necessary, and include most ICH and custom storage conditions. The company can support studies for shelf-life and expiry dating after long-term storage, reconstitution, or dilution; freeze-thaw, UV and visible light exposure; or moving from one storage condition to another (e.g., transfer from refrigeration to room temperature).
- cGMP LAB SERVICES – CMC Pharma offers cGMP lab services to support product development. These services include upgraded laboratory SOPs and documentation practices to comply with U.S. FDA guidelines. Data generated in CMC’s labs may be included or used to support clients regulatory filings with the U.S. FDA when cGMP lab studies are required. These documents can be included in U.S. FDA submissions and other worldwide markets when needed.
- CMC PHARMA CONSULTING – CMC Pharma has a proven track record in evaluating, developing, and manufacturing drug products for global markets. Our wealth of experience in the development and manufacturing of a wide range of drug products uniquely qualifies CMC Pharma to identify strategic solutions for the most demanding drug development programs. CMC Pharma provides phase-appropriate technical expertise to satisfy FDA and other worldwide regulatory requirements helping to ease the pathway to regulatory approval.
CMC Pharma’s laboratories in Cleveland and Solon, Ohio are well equipped for the formulation and analysis of pharmaceutical drug products. This allows CMC to provide valuable technical expertise on a broad range of drug product development disciplines for both short term and multi-year projects and provide customers with critically needed drug product development functions.
“CMC Pharma’s updated website more accurately describes our commitment to developing robust formulations needed for drug approval and large scale manufacturing. Our organization is well positioned to provide chemistry, manufacturing, and controls expertise to the commercial pharmaceutical and biotechnology industries as well as the Federal Government,” stated Dr. Mike Radomsky, Founder and President of CMC Pharmaceuticals. “CMC works with our prestigious clients to advance their pharmacotherapies and medical countermeasures to address unmet medical needs.”
About CMC Pharmaceuticals, Inc.:
CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. CMC Pharmaceuticals delivers its specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development and consulting services to clients globally. CMC Pharmaceuticals offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile, solid, semi-solid/liquid, topical, long-acting, controlled release, and other complex dosage forms. www.cmcpharm.com
For further information contact:
Casey Loveland, Business Manager
CMC Pharmaceuticals, Inc.
7100 Euclid Avenue
Cleveland, OH 44103