Melissa A. Schmidt

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Melissa Schmidt is Counsel to Porzio, Bromberg & Newman and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department.  She advises on legal issues with the goal of minimizing regulatory and common law risks associated with all aspects of the development and sale of regulated products.  Having served as in-house counsel,  Ms. Schmidt brings an understanding of the client perspective and provides innovative solutions in support of corporate objectives.

 

Ms. Schmidt partners with clients to develop and facilitate compliant business processes related to corporate strategic change and integration initiatives and enterprise-wide contract management and oversight, including template development and negotiation guidelines.  She works with senior leadership to prepare board presentations and inter-company governance and  provide general legal  guidance related to R&D and commercial activities.  Ms. Schmidt also reviews and negotiates commercial and corporate agreements including license arrangements, partnerships, mergers and acquisitions, consulting, confidential disclosure, global clinical trial arrangements, manufacturing, laboratory services, and research and development. 

 

Ms. Schmidt also handles international matters including, providing regulatory guidance for submission to Health Canada, EMEA & Japan/China, advising corporate executives related to Canadian Privacy/PIPEDA, and supporting the review and negotiation of provincial pricing agreements for Canadian products.  She also addresses issues related to alliance management of on-going international partnerships, promotional review, litigation management, section 16 filings and review of grant processes and requests.

Practice

Industries

Bar Admissions

  • Massachusetts

Education

  • New England School of Law, J.D., Boston, Massachusetts, 2001
  • Regis College, B.A., Weston, Massachusetts, 1998