Dr. Colonna has a broad educational
background with a BS (Microbiology) from the University of Sciences in
Philadelphia (formerly the Philadelphia College of Pharmacy and
Science), a PhD (Molecular Biology) from the Johns Hopkins University, and a JD
from the Georgetown
University Law Center. He has published
extensively in several areas and has extensive regulatory
affairs experience.
In addition to his consulting
practice, Dr. Colonna holds academic appointments to teach
regulatory affairs writing. Dr. Colonna holds an assistant professorship in the
graduate department of biomedical writing at the University of
Sciences in Philadelphia and an adjunct professorship in the biotechnology
program at the Johns Hopkins University.
Dr. Colonna provides consulting
services in the scientific and regulatory aspects of a wide
range of medical devices and biologics with particular expertise in
the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs,
microarrays, and pharmacogenomics), medical device software (including
bioinformatics), and
biotechnology-based products.
Dr. Colonna's background is particularly useful
to clients
with biomedical products where the scientific/technical and regulatory issues
are closely intertwined and an understanding of both is required.
In
addition to his regulatory affairs experience, Dr. Colonna is also
the editor-in-chief of two Internet-based medical newsletters:
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