BIO-PHARM

clinical pharmaceutical testing services, including, but not limited to, the creation of regulatory filings with U.S. and international health regulatory agencies (such as FDA, CPMP); medical writing services; creation of development plans for biotechnology products and devices, selection of clinical and preclinical study sites; monitoring preclinical and clinical studies; computer data management of data from study case record forms and from other clinical sources, biostatistical consulting and analysis of data; regulatory consulting and representation of clients with regulatory authorities, and manufacturing consulting consisting of conducting mock FDA manufacturing site audits