Staff Members With Expertise In
"FDA Regulatory Submission Preparation / Review - IDE"

Angela Blackwell M.S.

CV

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Phone: 704-450-9934

Expertise in preclinical testing and biocompatibility of devices and combination products

Ronald A. Marchesani

CV

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Phone: 650-378-1303

Expertise in compliance audits, facility design evaluation and quality system development/evaluation/oversight for biotechnology products

Stuart Portnoy M.D.

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Phone: 703-466-0961

Expertise in developing successful regulatory strategies for medical devices across a wide range of therapies

Darin J. Weber Ph.D.

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Phone: 206-940-3923

Expertise in regulatory strategy and CMC development for cell-based therapies and engineered tissues

Daniel P. Offringa

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Phone: 703-739-5695

Expertise in electronic submissions

Michael Gross Ph.D, RAC

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Phone: 215-316-8394

Expertise in quality and regulatory affairs for drugs, biologics, medical devices, specializing in combination products.

Calley Herzog

CV

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Phone: 720-883-3633

Expertise in regulatory project management for all types of premarket submissions.

Stephen Rhodes M.S.

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Phone: 301-579-3700

Expertise in developing successful regulatory strategies for medical devices and combination products

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