Thomas E. Colonna Ph.D./J.D.

Biotech Consultant LLC

FDA Regulatory Affairs Biotechnology Consultants


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:



For more information, contact Dr. Colonna