Find Lawyers in Miami, Florida for Biotechnology and Life Sciences Practice
Paul Radensky, MD, advises manufacturers at every stage of product development, including the design and monitoring of clinical trials, positioning and applying for Food and Drug Administration (FDA) approval, maintaining regulatory compliance, and obtaining coverage, coding and payment for new technologies by Medicare, Medicaid and other third-party payors. He serves as a principal of McDermott+Consulting LLC. Read full biography: https://www.mwe.com/people/radensky-paul-w/
Biotechnology and Life Sciences Practice Definition
The commercial success of these companies often depends on their ability to protect their intellectual property rights, to develop and commercialize their products in conformity with FDA and other regulatory requirements, to successfully raise financing from all available sources in both good and bad economic conditions, and to partner with larger companies in the industry to help bring their innovative products to the market. As a result, life sciences companies require significant legal expertise in the fields of intellectual property, FDA regulations, marketing compliance, licensing and collaborations, venture capital financings, public offerings, mergers and acquisitions, and commercial agreements unique to the industry, such as biologic and pharmaceutical manufacturing, supply, distribution, and co-promotion agreements. Biotechnology lawyers must be experts in one or more of these fields and be able to work collaboratively with legal experts in related fields.
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