Business consulting and management in the field of research and development and clinical trials for biotechnology, pharmaceutical, and medical device companies, namely, assisting companies with developing strategies and road maps for research and development; assisting companies with disease indications assessment, evaluations and clinical plan development; assisting companies with clinical site selection and trial feasibility; assisting companies with clinical trials compliance; assisting companies with concept, protocol development and implementation; assisting companies with all types of biomarkers selection, validation, qualification, and implementation in non-clinical and clinical research; assisting companies with review and management of development processes, clinical research organizations (CRO), drug manufacturing, and in-house and out-sourced functions and activities; assisting companies with clinical data and regulatory submission management for genetics, epigenetic, biologics and small molecule therapeutics, drugs, combination drug/device products and medical device approvals; and assisting companies with developing global regulatory approval strategies and navigating the regulatory submission and approval process