We bring unique expertise combining program and regulatory strategy, health policy, informatics, and analytics in federal program development and systems design.
Addwin Consulting Corporation, an Economically Disadvantaged Women-Owned Small Business (EDWOSB), is a health policy and strategy consulting firm with over 20 years of leading experience and expertise in:
- Regulatory affairs
- Healthcare analytics
- Clinical informatics
- Population health
- Electronic health record (EHR) system development
Addwin Consulting has completed strategic health IT engagements with USA government agencies (VA, HHS, DoE, DoD), commercial entities, and nonprofit health concerns. Our staff brings extensive experience at the Veterans Administration in developing innovative health IT applications, including the first guideline-based decision support system to be successfully deployed clinically at the VA which used both current transactional and CDW data and the first combat-tailored field clinical protocol models for DoD. We have also advised on the development of the performance architecture framework for health IT and program acquisitions in OIT, interoperability and mental health metrics development for the IPO, the value-management framework for performance analytics in VHA OIA and DoD-VA IPO, and the VHA analytics strategic plan for OABI. Our efforts also include voluntary service on federal committees including the VA HSR&D Informatics FACA.
Leadership
Mona Advani
Mona Advani, CEO of Addwin Consulting, is a recognized leader in the medical device industry with 23 years of professional experience in domestic and international regulatory affairs with a focus on business strategic goals. She has had extensive experience in the medical device industry holding the titles of Senior Director of Regulatory Affairs and Clinical Research, Manager of Business Development, Manager of U.S. Regulatory Affairs, Manager of International Regulatory Affairs, and Regulatory Affairs Coordinator. Mona has worked with small and large medical device companies to develop regulatory and clinical strategies, focusing on the appropriate development of corporate and product development strategy together with regulatory and clinical affairs. She has successfully obtained marketing clearance for a variety of medical devices, both in the United States and internationally, including the European Union (EU), Japan and Canada. Mona and her team work diligently to prepare and represent clients in regulatory meetings with FDA and other Regulatory Agencies. The Addwin regulatory and quality affairs team have expertly prepared numerous 510(k) and IDE Applications, and assisted in responses to FDA compliance actions and 483 letters.
In addition, Mona is fluent in written and spoken Japanese. She earned her MBA degree from San Francisco State University, her MS degree in Immunology and Infectious Disease from the University of London, and her BS degree in Biology from Brown University. Mona has organized international regulatory affairs workshops; presented at the RAPS Annual Regulatory Affairs Professionals Society Meeting; and published articles in the Regulatory Affairs Focus magazine.
Dr. Aneel Advani
Dr. Aneel Advani is a board-certified physician informaticist and a leader in applying health information technology to improve the health of communities and populations and advance public health and population medicine. Dr. Advani is Chairman of Global Virtual Group and President of Addwin Consulting Corporation. Dr. Advani also serves as an adjunct professor of Health Policy and Management and teaches healthcare strategy and policy at Johns Hopkins University. Dr. Advani has served as the Associate Director for Informatics/CMIO at the Indian Health Service, Associate Director for Technology/CTO at the National Center for Public Health Informatics at the CDC, and senior steering group on Health IT R&D under the White House Office of Science and Technology Policy.