Jun 18 2010
Ricerca Biosciences, an industry-leading, integrated preclinical contract research organization (CRO) providing services to the chemical and biopharmaceutical industries, is pleased to announce services it can now provide under its United States Drug Enforcement Administration (DEA) license.
“We are proud of our track record and dedication to excellence supporting this license, and more importantly, the license signifies our commitment to rapidly moving projects forward.”
Ricerca possesses a current DEA license, which allows Ricerca to handle multiple kilos of agency-controlled Schedule II-V substances for research and development projects at its Concord, Ohio, facility. This would include preparation of Phase I to Phase II clinical bulk API supplies.
As the mission of the DEA is to enforce the controlled substance laws and regulations of the United States, it only licenses highly reputable companies to handle and produce controlled substances. Crucial criteria distinguished by the government agency include documented accountability of material usage and disposal, secure storage and strong ICH Q7A compliance. In addition, a team of experienced chemists to execute the complex synthetic routes, as well as an experienced analytical chemistry group to perform IPC testing and method development work are also a necessity.
"We have the ability to move forward on clients' R&D projects that require a DEA license with no delay," stated Rich Donaldson, Ph.D, vice president of chemical development at Ricerca. "We are proud of our track record and dedication to excellence supporting this license, and more importantly, the license signifies our commitment to rapidly moving projects forward." Dr. Donaldson is responsible for process chemistry, radiosynthesis, process development and engineering and analytical chemistry.
Ricerca offers a unique spectrum of services for the areas of agrochemical registration, environmental analysis and preclinical discovery and development for biopharmaceutical registration.
SOURCE Ricerca Biosciences