Business consulting and management in the field of clinical trials, namely, clinical data and regulatory submission management on behalf of medical, biopharmaceutical and biotechnology companies to assist them with clinical research, clinical trials and applications for drug approval; Providing consulting services in the field of regulatory submission management to medical companies to assist them with applications for medical device approval; Regulatory submission management, namely, assisting others in preparing and filing applications for new drugs with governmental regulatory bodies; Regulatory submission management, namely, assisting others in preparing and filing applications for drugs, biologics, and devices with governmental regulatory bodies