We take a comprehensive and multidisciplinary approach to serving the legal needs of pharmaceutical, biotechnology, and medical device sectors.
We have worked on matters touching nearly every Life Sciences company in the Fortune 100 over the past 25 years, and have extensive experience with regulations, compliance, products, marketing, and IP, as well as medical, scientific, and device expertise. Whether a matter requires informal consulting, strategic advice on data-centric policies, technology workflow to reduce data, or effective review teams to control cost, our project managers and review attorneys have the know-how to move any matter through the internal, litigation, contracting, or regulatory process and deliver customized approaches in order to get the job done right.
Some of our experience includes:
Product liability regarding patient outcomes after widespread use prescription drug
ANDA litigation over generic manufacturer challenging patentability of formula
Internal email compliance sweep for marketing practices
SEC investigation into company’s public statements
50-state class action against medical device manufacturer
Government promotion and marketing inquiry
Controlled substance litigation
Asset purchase indemnification claim
Challenge to device manufacturer supply agreement