Michael Gross, Ph.D., RAC

Michael GrossPrincipal Consultant 
Chimera Consulting North America LLC

Michael Gross is the Principal Consultant of Chimera Consulting North America LLC, a consultancy specializing in quality assurance, regulatory affairs and technical development of drugs, biologics, medical devices and in particular combination products.

Michael has worked in the medical products industry for over thirty years in senior quality, compliance and regulatory affairs roles and has gained broad and deep understanding and experience in the development and regulation of drugs, biologics, medical devices and combination products. He has personally written and/or managed the submission of a variety of investigational exemption applications, marketing applications and other FDA regulatory filings and has made counterpart filings to European Health Authorities. He is a former FDA biologics reviewer and inspector.

During the past 25 years Michael has provided an influential industrial perspective on the regulation of combination products. He is a frequent speaker on combination products topics at industry meetings and has published numerous articles in regulatory and scientific publications.

A summary of his Curriculum Vitae is provided here click to open