Elizabeth A. McGuire
Counsel Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Elizabeth McGuire works with pharmaceutical, biotechnology, and medical device companies throughout the world on regulatory contracting matters, and leads the firm’s global clinical contracting practice.
Collaborating closely with members of the firm's Regulatory, Corporate, and Intellectual Property Practice Groups, Elizabeth drafts and negotiates clinical trial agreements, master services agreements, consulting agreements, investigator-initiated study agreements, pharmacovigilance/safety data exchange agreements, quality agreements, and other forms of regulatory agreements.
Elizabeth has an extensive corporate law background, advising clients on a broad range of corporate transactions, including mergers and acquisitions, joint ventures, and technology acquisitions. Building on this experience, Elizabeth's practice now largely focuses on providing contract support to life sciences companies that develop and commercialize pharmaceuticals, medical devices, and biotechnology products.
Representative experience
Assist pharma and biotech companies on complex commercial agreements such as CRO Master Services Agreements, Pharmacovigilance Agreements, Vendor Service Agreements, and Clinical Trial Agreements.
Assist multiple pharma and biotechnology companies with global clinical trials issues, including EU/GDPR privacy issues.
Advise medical device companies on clinical trial contracting issues; including drafting Clinical Trial Agreements.
Successfully negotiate multiple CRO Master Services Agreements and advise on CRO issues.
Successfully negotiate clinical trial agreements for pharma, biotech, and device companies.
Credentials
- J.D., University of California, Los Angeles School of Law, 2004
- M.S., Boston University, with distinction, 1995
- California