Ricerca Biosciences is an established preclinical Contract Research Organization located near Cleveland, Ohio, with over 25 years’ experience in drug and agrochemical development.
Our diverse capabilities include lead optimization studies (non-GLP early stage screening PK and toxicity work), GLP-compliant single and multiple dose toxicity studies, safety pharmacology studies, long term toxicity studies and metabolism studies employing radiolabeled test articles.
We have completed work with a wide variety of test articles, including pharmaceuticals, vaccines, agrochemicals and chemicals. We can work with all common laboratory animal species from rodents to non-human primates, and all common routes of administration including oral (dosing and dietary), dermal, injection and infusion. Our Study Directors are well versed in all applicable regulations and have extensive experience in designing studies and testing programs that meet international requirements for regulatory submission.
We have in-house support for clinical pathology and anatomic pathology. Our analytical team develops and validates methods for dose and diet analysis and our bioanalytical team develops and validates methods for parent compound and metabolites in complex biological matrices (blood, plasma, urine and tissues) using state of the art technology in support of discovery, preclinical and clinical studies.
We have robust systems for data capture and management (including Provantis and Watson LIMS) and our quality assurance systems meet all required international GLP standards.
We also offer a full chemical development suite that includes analytical characterization and method development, storage stability, radiochemistry, API manufacture in support of IND studies (GLP characterized) in addition to API manufacture with cGMP controls to support both clinical studies and commercialization.