Svetlana Lyapustina Ph.D.

Sr. Director, Science, Regulation & Policy

Overview

Svetlana Lyapustina, Ph.D., applies her rigorous scientific training to help health and life sciences stakeholders address regulatory and technical challenges. She advises individual companies and industry consortia on scientific innovation, patient safety, and product and device regulatory approaches. Her experience includes consulting on medical product development (pharmaceuticals, medical devices, biologics and combination products), quality control, development and manufacturing, regulatory compliance, patient adherence, and regulatory expectations.

Svetlana works with companies and industry consortia composed of industry, government and academia representatives to proactively address regulatory hurdles and policy mandates throughout the medical product development lifecycle. She has represented clients in interactions with regulatory, governmental and scientific agencies in the U.S. and other world regions, including:

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Health Canada
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • U.S., British, Japanese and European Pharmacopoeias (USP, BP, JP and EP)
  • International Organization for Standardization (ISO)

Credentials

Education

Johns Hopkins University
Ph.D. (1999)

Moscow State University, Moscow, Russia
M.S. (1989)

Insights & Events

Latest
Insights
Updates April 2020

Testing Employees for COVID-19: Responses to FAQs From Employers

4 min read  
Updates March 2020

FDA Relaxes Modification Restrictions for Non-Invasive Remote Monitoring Devices During COVID-19 Public Health Emergency

4 min read  
Updates February 28, 2018

Regulatory Considerations for Cybersecurity and Data Privacy in Digital Health and Medical Applications and Products

1 min read  
Updates Dec-06

Quarterly Publication of the Drinker Biddle Gardner Carton Health Law Pharmaceutical Practice Group: Focusing on Regulatory Science News and Issues

1 min read  
Updates Aug-06

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates Jun-06

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates Mar-06

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates Dec-05

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates June 2005

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates March 2005

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  

Leadership & Community

Professional Associations

  • American Association of Pharmaceutical Scientists
  • American Chemical Society
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