Litigation Support/Expert Witness

• Assist attorneys prepare for trial by evaluating and analyzing FDA related issues in a broad range of legal actions including medical mal-practice, breach of contract and qui tam actions
• Provide expert witness service regarding compliance with FDA requirements

Regulatory Consulting

• Assist industry in complying with FDA requirements
• Assist attorneys in defending against FDA enforcement actions

All services are based on my 14 years with FDA as an investigator, specialist and compliance officer, as well as a thorough knowledge of current regulations, and internal FDA manuals on inspections and compliance.