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Home     Consultants     Thomas E. Colonna


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.

In addition to his consulting practice, Dr. Colonna is the Associate Director of the Bioscience Regulatory Affairs program at the Johns Hopkins University. He has published extensively in several areas including authoring and editing two books published by the Food and Drug Law Institute: Promotion of Biomedical Products: Regulatory Considerations and Biomedical Software Regulation. Dr. Colonna is also the founder and director of the Regulatory Affairs Institute.

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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