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Starting on Oct. 1, 2019, CMC Pharmaceuticals will focus on upgrading laboratory SOPs and documentation practices to comply with FDA guidelines.
CMC Pharmaceuticals, a pharmaceutical and biotechnology drug product development services and manufacturing support company, announced additions to its Solon, OH, good manufacturing practices (cGMP) lab services starting on Oct. 1, 2019.
The addition will focus on upgrading laboratory SOPs and documentation practices to comply with FDA guidelines, according to a Sept. 10, 2019 press release. With the additions, data generated in the company’s laboratory may be included or used to support their contract customer’s filings with FDA when cGMP laboratory studies are required. The company can also 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’ FDA submissions.
“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, in the press release. “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.”
Source: CMC Pharmaceuticals