CHRIS FANELLI is a former FDA enforcement lawyer and has more than a decade of experience counseling life sciences companies on sensitive compliance and regulatory matters. He uses his experience as a former FDA official to assist clients with developing and implementing strategic action plans that meet the Agency’s expectations while also achieving his clients’ business objectives.
Chris’ practice sits at the intersection of FDA regulatory and FDA compliance. In addition to leading internal investigations into sensitive manufacturing compliance matters, managing critical FDA inspectional matters, and counseling on a variety of GxP compliance matters, he also routinely counsels clients on critical regulatory matters. This includes developing and implementing strategies to address Complete Response Letters, responding to Information Requests, and strategic FDA engagement.
Chris is actively involved in Sidley’s China Life Sciences Practice, and regularly speaks at Peking University’s International Pharmaceutical Engineering Management (IPEM) program on FDA matters and international crisis management.