Description: I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 19+ years as a consultant in my own pharmaceutical development advisory firm, I have contributed to regulatory approvals for over 50 drug and drug/device applications, and have provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.

Location: Redding, CT