Biotech Consultant LLC

FDA Regulatory Affairs Biotechnology Consultants


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 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, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products. 


For more information, contact Dr. Colonna

1148 Pulaski Hwy
Suite 107-342
Bear, DE 19701-1306

Ph: (302) 292-8342

Fax: (801) 681-5619