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Suchira Ghosh is an associate in the firm's New York office and practices primarily in the areas of intellectual property litigation and food and drug law. Ms. Ghosh's practice focuses on patent and regulatory issues unique to the pharmaceutical industry, including patent litigation and counseling. In addition, she has litigated disputes involving new chemical entity exclusivity and false labeling and advertising under the Lanham Act. Ms. Ghosh also provides counseling services relating to FDA matters, including drug and biologic approvals, citizen petitions, marketing exclusivities, patent listing, bioequivalence, labeling, certification and notification requirements, and issues involving recent tobacco legislation.
Prior to law school, Ms. Ghosh worked in the pharmaceutical industry for four years as a process engineer with Schering-Plough Research Institute's Sterile Pharmaceutical Product Development group. At Schering-Plough, she was responsible for developing and optimizing manufacturing processes for new drugs, including injectables, inhalers, live viruses and lyophilized products from laboratory to commercial scale, and transferring processes between research and commercial facilities within the United States, Canada, England, Belgium and France. Ms. Ghosh has extensive experience with GMPs and aseptic practices, compliance and validation, and she has assisted in the preparation of regulatory documents for submission to FDA, including INDs and NDAs. While at Schering-Plough, she worked frequently with cross-functional teams, gaining experience in various aspects of product development, including R&D, clinical, analytical, toxicology, pharmacokinetics and manufacturing.
Ms. Ghosh also interned with Pfizer and the Office of Policy within the Office of the Commissioner at the Food and Drug Administration.
She is licensed to practice before the U.S. Patent and Trademark Office.
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