CMC Pharmaceuticals has added current Good Manufacturing Practices (cGMP) lab services at its Solon, OH location on October 1st. This addition includes the upgrading of laboratory SOPs and documentation practices to comply with U.S. FDA guidelines. Now, data generated in CMC’s lab may be included or used to support contract customer’s filings with the U.S. FDA when cGMP lab studies are required. CMC Pharmaceuticals can now develop or improve drug product formulations, prepare prototypes of a variety of dosage forms, conduct stability and material compatibility studies, and create or optimize analytical methods that are suitable for inclusion in their clients U.S. FDA submissions.
This upgrade in capability extends CMC Pharmaceuticals ability to support their customer’s needs in drug product development services. “We started this organization five years ago to help pharma and biotech companies develop robust drug products faster,” said Mike Radomsky, Founder and President of CMC Pharmaceuticals. “This logical expansion of our service offering is in response to the expanding needs of our valued customers and allows us to directly support them with their submissions to the FDA”.
CMC Pharmaceuticals continues to operate its Mid-town Cleveland laboratory with a focus on R&D services, providing for early stage research laboratory services.