EXPERT ADVISORS. EXACT PRACTICES.

Identification of regulatory strategies for product market applications and reimbursement; preparation and submission of product applications to the FDA and other regulatory agencies; preparing business reports for governmental agencies and medical journals resulting from clinical studies; providing reimbursement and health economic services, namely, researching and analyzing current reimbursement policies, product and procedure codes and pricing; providing due diligence services, namely, evaluating regulatory strategies, clinical strategies, product reimbursement strategies and quality systems on behalf of venture capitalists

Contract regulatory and clinical services, namely, strategy development in the nature of consulting services regarding scientific and technical aspects of clinical trials and submissions to the FDA and other regulatory agencies; designing, implementing and managing clinical trials for product testing and development purposes; developing and managing clinical studies, clinical protocol, data management and analysis for clinical trials; preparing scientific reports resulting from clinical studies; developing and managing regulatory quality systems and compliance matters for medical product manufacturers; designing and implementing pre-clinical research services, namely, scientific animal research; preparing scientific reports as to results of studies for governmental agencies and medical journals resulting from clinical studies; designing animal medical experiments; designing, implementing and analyzing human clinical studies, namely, protocol development, site initiation, database development and management and data analysis