"Regulatory Affairs is an integral part of any company looking to successfully sell their biomedical products in today's market. FDA requirements and policies frequently change, drastically affecting the product approval process."

Biotech Consultant LLC provides consulting services in the scientific and regul atory 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, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics),medical device software (including bioinformatics), CPT coding reimbursement, and bio-technology-based products.

For more information, contact

Dr. Thomas E. Colonna
1148 Pulaski Hwy
Suite 107-342
Bear, DE 19701-1306

Ph: (302) 292-8342
Fax: (801) 681-5619