Drug companies face pressure from many directions a foreboding regulatory landscape, competitors with alternative brands or generics and push back from insurers.
At the same time, they can find opportunities in maximizing the benefits of statutes that encourage new drug development. Whether you’re a global pharmaceuticals company or a biotechnology startup, accomplishing business goals in such a highly regulated industry requires practical, integrated legal analysis and advice.
We are creative in solving your problems thanks to our background and experience. We not only know the law, we know the nuances of the law because many of our lawyers have worked in the U.S. Food and Drug Administration. Others have worked in industry, which means we also understand your business, the science behind your business, and your marketplace.
Our services are as varied as the challenges you face. We offer timely, effective counsel on matters that include product development, approval, post-approval compliance, and the development of next-generation products. Our lawyers concentrate on particular areas of the law, such as advertising, manufacturing compliance, regulatory exclusivities, and controlled substances. And when your issues overlap with other disciplines, such as intellectual property, litigation, or health care compliance, we reach across the firm to tap into the needed expertise, especially in our strong health practice.