Leveraging her prior experience in public health and post-market surveillance research for drugs and devices, Ashley counsels clients on a variety of questions related to FDA's complex regulatory landscape. Ashley's practice includes: product development, product lifecycle management, pharmacovigilance, human cell and tissue products, Good Clinical Practice, advertising and promotion, bioresearch monitoring, human subject protection, Freedom of Information Act, compounding, device 510K clearance, imports and exports, and due diligence.