Pharmaceutical

We are among the few teams in the nation that can navigate the complex landscape of pharmaceuticals and the Food and Drug Administration (FDA). By combining our Washington, DC presence with deep pharmaceutical regulatory, compliance and litigation experience, we advise clients on matters tied to:

●     FDA regulations regarding medical device regulatory and recall issues (including 510k and and product recalls)
●     FDA clinical trials and FDA product testing oversight
●     Laboratories
●     DEA regulations (abuse of a drug)
●     DOJ pricing investigations
●     Medicare and Medicaid suspected fraud cases
●     Clinical trial representation
●     Domestic and International counsel
●     FDA reviews and investigations
●     Average wholesale pricing reviews
●     Pharmacy benefit managers(PBM’s) and  genomic testing and laboratories

Our legal leaders are always one step ahead and bring high-level experience in clinical trial representation before the DOJ, the FDA and Congress. We have taught some of the first law school courses in blockchain technology and are involved in the creation of the first multi-university blockchain institute in the country. As such, we demonstrate a significant, multilayered and immersive appreciation for the significant role of this technology and its impact on the pharmaceutical industry. As creative, solutions-oriented professionals, we look at how we can apply our understanding of key trends and futurecast potential impact.