With over 30 years of experience in the legal industry and a background as a paralegal, Hannah focuses on helping life sciences companies navigate FDA compliance and state regulatory licensure matters.
Experience
Representative matters
Representative matters
Assessment and licensure assistance for conventional and virtual drug manufacturers.
Assessment and licensure assistance for medical device companies and DME suppliers.
Assessment and licensure assistance for service providers to the life sciences industry.
Assessment and licensure assistance for conventional and virtual drug manufacturers.
Assessment and licensure assistance for medical device companies and DME suppliers.
Assessment and licensure assistance for service providers to the life sciences industry.
Assistance with a wide range of FDA submissions.
FOIA requests.
Collaboration with corporate and tax colleagues to develop strategies for coordinated and phased license transfers in connection with corporate reorganizations.
Support for internal investigations on topics including good clinical practices (GCPs) and investigator selection, research grants, adverse event reporting, escalation of potential quality or safety concerns, and recalls and corrections.
Support for FDA diligence on medical device, biologics, and pharmaceutical targets.
Credentials
Education
Education
- University of Texas at Austin, 1982, B.A.
Professional affiliations
Professional affiliations
- Active member of the Austin fine arts community for the past 30 years