Challenge: A leader in assay and sample technology development for tests used in the pharmaceutical and molecular diagnostics industries needed a regulatory strategy for its analyte-specific reagent (ASR) diagnostic kits.

Beaufort Solution: After identifying pathways to a Class II device classification, Beaufort prepared a strategic regulatory plan for the test kit, enabling the company to satisfy regulatory requirements in a cost-effective manner.  Beaufort drafted a pre-IDE filing, including a clinical trial plan, and provided coaching to the client as it prepared for its pre-IDE meeting with the FDA.  After successful meetings with FDA officials, the company relies on Beaufort for continued support as necessary, including assisting with preclinical and clinical trial activities.

Date posted: October 31, 2011

Categories: Case Studies Regulatory Affairs