Lana Pauls, MPH

 Lana is an expert in regulatory strategy, regulatory affairs, FDA submission development and project management. 

Before embarking on consulting in 2018, Lana was Director of Global Regulatory Affairs for 2 years at CRO leader QuintilesIMS (now IQVIA), providing regulatory advice to the pharmaceutical industry regarding regulatory submissions to the FDA. She also served as the primary project manager and/or US Agent on various FDA applications. 

Previously, Lana spent 26 years at FDA in a variety of capacities, starting in 1990 as Project Manager in the Division of Metabolic and Endocrine Products (working for a while with Kinexum founder Zan Fleming), then as the Chief, Project Management Staff in the Division of Reproductive Products.  She was then named the Associate Director in the same Division, in which she served as a policy expert regarding FDAMA and PDUFA. 

In 2000, Lana was named the Director of the Quality Management Staff in the Office of Executive Programs, responsible for conducting quality assurance audits, as well as developing a quality system for the Center.  In 2009, she joined the Office of Surveillance and Epidemiology as the Associate Director for Executive Operations and Strategic Planning, responsible for long-range strategic planning, quality development and best-practice implementation as well as developing and implementing Office-wide training. 

Lana received her Masters degree in Public Health from the Uniformed Services University of the Health Sciences in 1993. In 1998 she completed a year-long Excellence in Government Fellows Program with the Council for Excellence in Government.  In 2006, Lana was selected as a National Examiner for the Malcolm Baldrige National Quality Program administered by the National Institute of Standards and Technology, and completed three years as an examiner for the program.