Christopher A. Fanelli

Christopher A. Fanelli

Senior Associate, Washington, D.C.

Christopher (Chris) Fanelli works closely with life sciences clients globally to develop and implement practical, forward-thinking strategies to address U.S. Food and Drug Administration (FDA) compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (GMP) requirements, data integrity responsibilities, import and export issues, and pharmacovigilance obligations.

Prior to joining Hogan Lovells, Chris served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel, where he handled GMP enforcement and provided legal counsel on a range of inspectional, compliance, and policy issues to agency components.

His agency and private practice experience equips him with the tools needed to assist manufacturers with preparing for FDA inspections; responding to FDA inspectional observations (a Form FDA 483), Warning Letters, and Complete Response Letters; resolving import alerts; and preparing for meetings with the FDA. Chris enjoys working alongside clients to identify risks early through on-site GMP assessments and investigations, including data integrity investigations and Part 11 assessments, and mock inspections.

Chris also guides life sciences and private equity clients through intricate due diligence matters relating to FDA compliance and enforcement, including pre-acquisition quality assessments and post-acquisition quality integration.

Education and admissions

Education

J.D., Boston University School of Law, cum laude, 2011

B.A., Juniata College, magna cum laude, 2006

Bar admissions and qualifications

District of Columbia

New York

Representative experience

Assist multiple Chinese pharmaceutical companies in responding to FDA enforcement.

Draft responses to FDA 483s and Warning Letters.

Conduct GMP assessments and data integrity investigations in the U.S., China, India, Japan, and Europe.

Resolve multiple Warning Letters for global pharmaceutical companies.

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