MedtechVISION 2024 Organizing Committee

Anisa Mohanty advises medical device, biotech, and pharmaceutical companies on US Food and Drug Administration (FDA) premarket strategy and post-market compliance issues, from advertising and promotion to disclosure and periodic reporting. Her experience encompasses such matters as premarket pathways, Good Laboratory Practice and Good Clinical Practice and Good Manufacturing Practice (cGMP) and Quality System requirements.

Her tenure as a Regulatory Counsel at the FDA now provides valuable perspective for clients in the life sciences industry. She offers guidance to her clients on the regulatory requirements and industry standards for the development, creation and review of advertising and promotional materials for drugs and medical devices. Anisa also supports investors and companies on scoping and development developing appropriate due diligence strategies for transactions and investments involving FDA-regulated drugs, medical devices, and other products.

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