Drugs

Few industries have such life changing impact on both a macro and a micro level as the pharmaceutical industry. With stakes high and many competing interests, all levels of government are heavily invested in making sure that pharmaceutical products are developed, tested and subject to the highest degrees of scrutiny when attempting to bring them to market.

Amin Wasserman Gurnani’s attorneys are embedded in the industry and offer keen insight into the changes in both the marketplace and in the legislative and regulatory space. We understand the issues from all sides:  we provide counseling both to companies looking to market prescription, OTC, and homeopathic human and animal drugs. We are particularly adept at navigating the intersections of FDA, IP, and antitrust laws.

We guide our clients through the evolution of their products, from initial development and testing through approval and challenges. In addition to acting as a strategic partner at inception, we remain with our clients when challenged by competitors and governmental agencies.  Our attorneys have strong relationships with the regulatory bodies, and our expertise is recognized by industry associations and peers.

We concentrate a large part of our work helping clients to solve legal problems when dealing with FDA compliance. Particularly, we help clients comply with the myriad of FDA statutes, regulations, and policies as they relate with drugs. This includes helping with product development, marketing reviews, registrations and approvals, and investigatory/enforcement issues.