Svetlana Lyapustina Ph.D.

Senior 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)

Insights & Events

Leadership & Community

Professional Associations

  • American Association of Pharmaceutical Scientists
  • American Chemical Society
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