Svetlana Lyapustina, Ph.D.
Principal
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)
Related Legal Services
Related Industries
Credentials
Education
Johns Hopkins University
Ph.D. (1999)
Moscow State University
M.S. (1989)
Insights & Events
Latest
Insights
News
Other Perspectives
Firm Blog Contributions
- Discerning Data – a forum that discusses developments in privacy, cybersecurity, information governance and data analytics
Leadership & Community
Professional Associations
- American Association of Pharmaceutical Scientists
- American Chemical Society