Partner

Maureen Donahue Hardwick is a partner in the Government and Regulatory Affairs Practice Group and is a member of the firm’s Pharmaceutical practice, concentrating on the formation and management of focused industry consortia that address common scientific, regulatory and policy goals of pharmaceutical, biotechnology and medical device companies.  Maureen’s practice includes serving as secretariat and legal counsel for several pharmaceutical consortia addressing a range of compliance matters affecting the pharmaceutical and health care industry in the U.S., the EU and other countries around the world.  Maureen represents a consortium of multinational pharmaceutical companies manufacturing asthma therapies that rely on propellants subject to regulation under the Montreal Protocol and Kyoto Protocol.  In this capacity, she has represented the consortium before international environmental bodies and has also periodically coordinated efforts of the consortium with patient advocacy groups.  Maureen provides support and counsel to an international group of chief privacy officers focused on compliance with U.S., EU and other national data privacy laws.  She has also managed a roundtable group that facilitates dialogue between Institutional Review Boards and sponsors of clinical research.

Maureen is active in the firm’s Public Interest Committee and “Green” initiative to promote environmental awareness and sustainable business practices.

Prior to joining the firm, Maureen worked at Venable, Baetjer, Howard & Civiletti as an associate in the environmental and the general litigation groups.

In General.  Maureen is a 1994 graduate of Washington University School of Law in St. Louis, Missouri, where she served as managing editor of the Washington University Journal of Urban and Contemporary Law.  She received her undergraduate degree from the University of Vermont.

She lives in Chevy Chase, Maryland with her husband, John, and their daughter, Emerson Lily.  Outside the office, Maureen enjoys nordic skiing, running and reading.

Maureen is a member of the State Bars of Maryland and the District of Columbia.