Philip E.M. Crooker, J.D.

Philip E.M. Crooker, J.D.

Philip E.M. Crooker, J.D.

Vice President - Technical

Mr. Crooker readily identifies, analyzes and capably resolves complex legal, regulatory, and technical issues in a high risk and heavily regulated environment. Mr. Crooker has a proven record of effectively counseling and communicating with organizations on the analysis of issues at the interface of product development and commercialization, regulation, and business; creating successful technical, regulatory and compliance strategies for all stages of pharmaceutical product lifecycle management; assessing and integrating new product acquisitions; and leading and growing business functions.

Work Experience

Mr. Crooker is a scientifically trained drug development attorney with a combination of U.S. Food and Drug Administration (FDA) and private sector experience in global large-cap, midsize specialty and closely held pharmaceutical and biotechnology companies. Mr. Crooker has accumulated extensive global professional and practice experience for 21 years in applying laws, regulations, and policy to successfully solve complex problems confronting pharmaceutical and biotechnology firms engaged in all stages of product development; chemistry, manufacturing and controls (CMC) and product quality strategy; the regulatory approval process and health authority engagement; product commercialization and lifecycle management; and drug manufacturing compliance and enforcement for both conventional commercial manufacturers and compounding pharmacies.

He has presented at numerous meetings for the American Association for Pharmaceutical Scientists (AAPS) and participates in the International Society of Pharmaceutical Engineering (ISPE), the Food and Drug Law Institute (FDLI) and the American Society for Testing and Materials (ASTM).

Education

Mr. Crooker holds an undergraduate degree in chemistry and a law degree. He remains an active member of the California Bar and has also been admitted to the U.S. District Court for the Central District of California.

We are always available for a conversation.

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