Established in 2007, CRBio, the Clinical Research and Biosciences division of RA Chem Pharma Ltd, is a Hyderabad, India-based regulatory class CRO which has been inspected and approved by several regulatory agencies like the DCGI, US FDA and MOH-Turkey. Apart from these, submissions have been made to world-class regulatory agencies such as UK MHRA, EMEA, BPFK-Malaysia and PAHO.
The facility is spread over 30,000 sq. ft. in well laid out areas in the operations such as Clinical, Bioanalytical, Pharmacokinetic & Statistical, Medical Writing, QA & RA, and QC. With full time doctors and paramedical staff, clinics consist of 114 beds segregated into 5 independent clinics and with a 5000 volunteer database, with a state of the art bioanalytical laboratory consisting of 5 LC-MS/MS, having over 80 methods with most of them validated, storage -86 & -30 deep freezers.
In a short span of 5 years, CRBio, which is independent in the truest sense, unaffiliated, has completed over 220 BA/BE projects. Growth plans have been initiated when CRBio has forayed into patient population studies in the areas of oncology and anti-psychotic bioequivalence projects. Further growth plans are on the anvil and CRBio is likely to foray into POC, CEP, pre-clinical and late stage clinical trials in a progressive manner. CRBio acts as a catalyst to our sponsors’ initiatives and is more like a partner for a sponsor’s clinical trial requirements. Hence, the support is on a continuous basis, starts with the project and continues post project, both in evaluations and in regulatory query resolutions.