Anisa Mohanty

Practicing at the forefront of the life sciences industry, 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.

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. She has a particular focus on advising companies on FDA advertising and promotion strategies and compliance processes leveraging her prior experience as a regulatory counsel at FDA.

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.

Her tenure as a Regulatory Counsel at the FDA now provides valuable perspective for clients in the life sciences industry. During her time with the organization, Anisa advised agency policymakers, regulatory and enforcement personnel on the development and implementation of a new regulatory regime for tobacco products as well as the development of interpretative guidance and regulatory policies. She was also responsible for counseling compliance and enforcement personnel on matters related to product labeling, advertising and marketing; conducting routine and directed inspections of manufacturing establishments and investigations of distribution and marketing activities; and coordinating enforcement actions.