Genevieve Razick leads clients through the landscape of FDA regulations, particularly pertaining to pharmaceuticals, biologics and medical devices. FDA regulations and pharmaceutical compliance initiatives can require a lot of companies — and Genevieve is poised to help you every step of the way. From annual establishment registration and product listings to product classification, marketing and other compliance issues, she has the knowledge and experience to be your strategic business partner.
Genevieve supports pharmaceutical and medical device companies as they draft and review policies, contracts, marketing materials, product dossiers, and documents for formulary committees and advisory boards. She has served as the legal reviewer on a number of promotional review committees for pharmaceutical and medical device companies. She also advises companies regarding Sunshine Act reporting, PhRMA Code compliance, and fraud and abuse risks under the federal Anti-Kickback Statute. When companies prepare for clinical trials, Genevieve shares her perspective to develop and review informed consent documents and other relevant material.