Justin Yu

Justin Yu

Senior Associate, Los Angeles

Email justin.yu@​hoganlovells.com

Phone +1 310 785 4642

Fax +1 310 785 4601

Practice groupRegulatory

Justin Yu provides practical regulatory compliance and contracting advice to pharmaceutical and biotechnology companies of all shapes and sizes in order to help them achieve their business goals.

With a background in microbiology, Justin advises various players in the drug and biologics arena on Food and Drug Administration (FDA) regulatory matters in light of their respective business model and products.

As part of his practice, he drafts and negotiates regulatory terms and contracts on behalf of sponsors, applicants, application holders, and others, including clinical trial agreements, investigator-initiated study agreements, contract research organization (CRO) agreements, consulting agreements, quality agreements, safety data exchange/pharmacovigilance agreements, and informed consent forms.

Justin also provides guidance to companies on regulatory issues at various stages of drug development, including issues related to clinical trials, good clinical practice (GCP) requirements and standards, marketing approval, life science mergers and acquisitions, and postmarket compliance programs.

Education and admissions

Education

J.D., The University of Chicago Law School, with honors, 2013

B.S., University of California, Los Angeles, with honors, 2008

Bar admissions and qualifications

California

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