CHRISTOPHER FANELLI is a former FDA enforcement lawyer and a partner in Sidley’s Food, Drug and Medical Device group.
First in government as an Associate Chief Counsel for Enforcement in FDA’s Office of the Chief Counsel and now in private practice, Chris focuses his practice on compliance with GMP and GLP requirements at the pre-clinical, clinical, and post-approval stages; data integrity responsibilities; import and export issues; and pharmacovigilance obligations.
Chris’ clients include pre-commercial and early-stage commercial life sciences companies, as well as global small molecule drug manufacturers, large molecule biologics manufacturers, CAR T and gene therapy manufacturers, API manufacturers, animal health companies, combination product manufacturers, and device manufacturers. Clients count on Chris to anticipate, provide strategic guidance on, and resolve their critical FDA enforcement and compliance matters, including:
- Internal investigations;
- Preparing for and managing FDA inspections around the world;
- Responding to FDA inspectional observations (a Form FDA 483), Warning Letters, and Complete Response Letters involving facilities, quality, and CMC issues;
- Resolving import alerts; and
- Preparing for and attending make-or-break meetings with FDA.
Chris also supports private equity clients investing in FDA-regulated entities by performing FDA compliance due diligence assessments and by developing and implementing business-friendly compliance strategies at portfolio companies to ensure sustained compliance with FDA’s regulations.
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 compliance and enforcement matters and international crisis management.