NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Lana L. Pauls, MPH

Practice Area Focus

  • Drugs
  • Generics
  • Biologics
  • Development Strategy
  • Regulatory Affairs
  • Regulatory Submissions
  • Program Management

Biography

Lana Pauls joined NDA Partners as an Expert Consultant in 2018. Ms. Pauls is a regulatory affairs expert with extensive project management experience at the US FDA in the Center for Drug Evaluation and Research (CDER) and at IQVIA (formerly QuintilesIMS).

Ms. Pauls served in several senior roles at FDA CDER as Director, Executive Operations and Strategic Planning, Office of Surveillance and Epidemiology (OSE); Senior Advisor for Quality, Office of Planning and Analysis (OPA); Director, Quality Management Staff, Office of Executive Programs (OEP); Associate Director, Office of the Center Director, Review Standards Staff; Associate Director, Office of New Drugs, Division of Reproductive and Urologic Products (DRUP); and Director, Drug Review Program, Office of Review Management.

Following her successful career at the FDA, Ms. Pauls served as Director, Global Regulatory Affairs at IQVIA, where she provided regulatory advice to a variety of clients and served as project manager and US Agent for regulatory submissions to the FDA.