Rochelle, Virginia (March 14, 2018) – NDA Partners Chairman Carl Peck, MD, announced today that Lana L. Pauls, a regulatory affairs expert with extensive project management experience at the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and at IQVIA (formerly QuintilesIMS), has joined the firm as an Expert Consultant.
While at the FDA, Ms. Pauls served 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 26-year career at the FDA, Ms. Pauls served as Director, Global Regulatory Affairs at IQVIA, where she provided regulatory advice to clients and served as project manager for regulatory submissions to the FDA.
“Ms. Pauls’ thorough knowledge and experience in regulatory strategy and managing regulatory submissions, in addition to her experience at FDA CDER and IQVIA, are a welcome addition to our team of regulatory experts. We are very pleased that she has joined our team of Expert Consultants,” said Dr. Peck.
Ms. Pauls earned her Masters of Public Health degree from the Uniformed Services University of the Health Sciences in Maryland and a bachelor’s degree in animal bioscience from Pennsylvania State University. She is also a graduate of the University of Pennsylvania, Perelman School of Medicine, Center for Clinical Epidemiology and Biostatistics, FDA Pharmacoepidemiology Certificate Program.
About NDA Partners
NDA Partners is a life sciences management consulting firm focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and management of client product development programs.
Earle Martin, Chief Executive Officer