Mr. Kevin
Hennegan is the Senior Managing Consultant for CBR.
Mr. Hennegan has been involved in the biopharmaceutical
industry since 2001 and spent three years in Research
& Development for a biotechnology company in northern
California before joining CBR in 2004.
As part of his responsibilities at CBR, he provides
clients with strategic product development and regulatory
recommendations. He has participated in the development
of Quality Systems, provided oversight for Quality
Assurance and Quality Control departments, and assisted
with hosting FDA Inspections for a number of biotechnology
and pharmaceutical companies. He is an experienced
medical writer, having contributed to a number of
clinical study reports, authored clinical study protocols,
and lead the preparation of a briefing document for
an FDA Advisory Committee. Mr. Hennegan is a skilled
auditor, providing sponsors with assessments of their
Quality Systems, cGCPs and cGMPs. He is responsible
for several regulatory programs and has served as
the US Authorized Representative to the FDA for CBR’s
clients. He is also a member of the CBR management
team, providing guidance and oversight to CBR’s
consultants, associates and affiliates.
Mr. Hennegan received a M.A. in Molecular, Cellular
and Developmental Biology from the University of Colorado
at Boulder and a B.S. in Microbiology from Colorado
State University.
Consistent, thorough and up-to-date analysis of your
evolving needs is just the beginning of our commitment
to your program. For a comprehensive assessment of
your program requirements, please contact us by calling
(720) 746-1190 or by email at info@cbrintl.com.
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