Introduction to the Due Diligence Process v
About the Authors
Joanne S. Hawana, MS, JD, is a member of Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo PC’s FDA practice team. She counsels
global clients on regulatory and distribution-related considerations
to bringing a new FDA-regulated product to market and how to
ensure continued compliance after a product is commercialized.
Hawana also assists the Mintz corporate team by performing regu-
latory due diligence as part of potential mergers and acquisitions
that involve regulated companies, and she often works in conjunction with the firm’s
intellectual property attorneys to ensure that patent and regulatory activities are
strategically aligned. She holds an MS in molecular genetics and microbiology from
the University of Medicine and Dentistry of New Jersey and a JD from the
University of Maryland School of Law.
Benjamin M. Zegarelli, MS, JD, is a member of Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo PC’s FDA practice team. He
provides counsel on compliance and regulatory issues to clients in
the medical device, pharmaceutical and biotech industries. With a
clear focus on FDA regulatory counseling, Zegarelli advises a
breadth of health care industry and life sciences clients on the fed-
eral and state laws surrounding medical product development and
marketing. He also frequently leads regulatory due diligence reviews for transactions
involving pharmaceutical and medical device manufacturers and provides regulatory
advice to the Mintz corporate team on such transactions. Zegarelli holds an MS in
organic chemistry from the California Institute of Technology and a JD from the
Benjamin N. Cardozo School of Law.
Elizabeth K. Conti, JD, is a member of Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo PC’s FDA practice team. She focuses
her practice on regulatory compliance and enforcement defense
matters for companies in pharmaceuticals, medical device, dietary
supplement, cosmetics and food industries as well as pharmacies
and distributors. Conti advises clients on FDA regulations related
to labeling, advertising, importing and exporting, and manufactur-
ing practices. Her practice also encompasses administrative matters and civil
litigation related to DEA requirements. Conti holds a JD from the Catholic
University of America.
Scott P. Dunberg, JD, is a member of Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo PC’s corporate and securities practice team. He
represents public and private companies in a broad range of trans-
actions and corporate matters and focuses primarily on mergers
and acquisitions, venture capital financings, capital markets trans-
actions, securities law compliance and general corporate
representation. Dunberg regularly represents technology-based
companies, principally in the areas of biotechnology, med-tech, telecommunications,
and software. He holds a JD from Suffolk University Law School.
About the Authors
Joanne S. Hawana, MS, JD, is a member of Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo PC’s FDA practice team. She counsels
global clients on regulatory and distribution-related considerations
to bringing a new FDA-regulated product to market and how to
ensure continued compliance after a product is commercialized.
Hawana also assists the Mintz corporate team by performing regu-
latory due diligence as part of potential mergers and acquisitions
that involve regulated companies, and she often works in conjunction with the firm’s
intellectual property attorneys to ensure that patent and regulatory activities are
strategically aligned. She holds an MS in molecular genetics and microbiology from
the University of Medicine and Dentistry of New Jersey and a JD from the
University of Maryland School of Law.
Benjamin M. Zegarelli, MS, JD, is a member of Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo PC’s FDA practice team. He
provides counsel on compliance and regulatory issues to clients in
the medical device, pharmaceutical and biotech industries. With a
clear focus on FDA regulatory counseling, Zegarelli advises a
breadth of health care industry and life sciences clients on the fed-
eral and state laws surrounding medical product development and
marketing. He also frequently leads regulatory due diligence reviews for transactions
involving pharmaceutical and medical device manufacturers and provides regulatory
advice to the Mintz corporate team on such transactions. Zegarelli holds an MS in
organic chemistry from the California Institute of Technology and a JD from the
Benjamin N. Cardozo School of Law.
Elizabeth K. Conti, JD, is a member of Mintz, Levin, Cohn,
Ferris, Glovsky and Popeo PC’s FDA practice team. She focuses
her practice on regulatory compliance and enforcement defense
matters for companies in pharmaceuticals, medical device, dietary
supplement, cosmetics and food industries as well as pharmacies
and distributors. Conti advises clients on FDA regulations related
to labeling, advertising, importing and exporting, and manufactur-
ing practices. Her practice also encompasses administrative matters and civil
litigation related to DEA requirements. Conti holds a JD from the Catholic
University of America.
Scott P. Dunberg, JD, is a member of Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo PC’s corporate and securities practice team. He
represents public and private companies in a broad range of trans-
actions and corporate matters and focuses primarily on mergers
and acquisitions, venture capital financings, capital markets trans-
actions, securities law compliance and general corporate
representation. Dunberg regularly represents technology-based
companies, principally in the areas of biotechnology, med-tech, telecommunications,
and software. He holds a JD from Suffolk University Law School.